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Prempro

conjugated estrogens and medroxyprogesterone acetate · Tablet, Sugar Coated

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Prempro
Generic name
conjugated estrogens and medroxyprogesterone acetate
Dosage form
Tablet, Sugar Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
4
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
ESTROGENS, Conjugated .3 mg/1 150840 View
ESTROGENS, Conjugated .45 mg/1 150840 View
ESTROGENS, Conjugated .625 mg/1 150840 View
Medroxyprogesterone Acetate 1.5 mg/1 1000114 View
Medroxyprogesterone Acetate 2.5 mg/1 1000114 View
Medroxyprogesterone Acetate 5 mg/1 1000114 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Sugar Coated
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Conjugated (USP) [CS] CS 5 members — no class page
Estrogen Receptor Agonists [MoA] MoA All 45 members
Estrogen [EPC] EPC All 45 members
Estrogens EPC 5 members — no class page
Progesterone Congeners [CS] CS All 40 members
Progestin [EPC] EPC All 40 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
020527
Application type
NDA · New Drug Application
Approval date
November 17, 1995
Sponsor
WYETH PHARMS
Products on application
5
Submissions recorded
40
Products approved under application 020527.
Product Trade name Form Strength Ingredient Status TE Flags
020527-001 PREMPRO TABLET ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Prescription — RLD RS
020527-002 PREMPHASE 14/14 TABLET ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Prescription — RLD RS
020527-003 PREMPRO TABLET ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Prescription — RLD RS
020527-004 PREMPRO TABLET ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Prescription — RLD RS
020527-005 PREMPRO TABLET ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 020527.
Type No. Action Status Date Review
Supplement 67 Labeling Approved April 22, 2025 Standard
Supplement 68 Labeling Approved February 15, 2024 Standard
Supplement 65 Labeling Approved November 1, 2017 Standard
Supplement 63 Manufacturing (CMC) Approved May 4, 2016 Standard
Supplement 61 Manufacturing (CMC) Approved February 25, 2016 Standard
Supplement 62 Labeling Approved August 31, 2015 Standard
Supplement 59 Manufacturing (CMC) Approved July 1, 2014 Standard
Supplement 56 Labeling Approved February 2, 2012 Unknown
Supplement 54 Labeling Approved February 2, 2012 Unknown
Supplement 52 Manufacturing (CMC) Approved February 2, 2012 Standard
Supplement 51 Labeling Approved February 2, 2012 Unknown
Supplement 45 Labeling Approved December 30, 2009 Standard
Supplement 46 Manufacturing (CMC) Approved May 18, 2009 Standard
Supplement 43 Labeling Approved March 3, 2008 Standard
Supplement 37 Labeling Approved July 27, 2006 Standard
Supplement 36 Labeling Approved June 30, 2005 Standard
Supplement 35 Labeling Approved April 20, 2004 Standard
Supplement 34 Labeling Approved April 20, 2004 Standard
Supplement 31 Labeling Approved June 4, 2003 Standard
Supplement 26 Labeling Approved June 4, 2003 Standard
Supplement 24 Efficacy Approved June 4, 2003 Standard
Supplement 17 Efficacy Approved March 12, 2003 Standard
Supplement 30 Labeling Approved January 7, 2003 Standard
Supplement 29 Labeling Approved November 27, 2002 Standard
Supplement 25 Manufacturing (CMC) Approved July 10, 2002 Standard
Supplement 18 Labeling Approved February 11, 2002 Standard
Supplement 21 Manufacturing (CMC) Approved December 3, 2001 Standard
Supplement 15 Labeling Approved January 6, 2000 Standard
Supplement 14 Manufacturing (CMC) Approved March 18, 1999 Standard
Supplement 13 Labeling Approved May 12, 1998 Standard
Supplement 9 Labeling Approved March 10, 1998 Standard
Supplement 6 Efficacy Approved January 9, 1998 Standard
Supplement 8 Manufacturing (CMC) Approved August 8, 1997 Standard
Supplement 4 Labeling Approved July 31, 1997 Standard
Supplement 7 Manufacturing (CMC) Approved June 30, 1997 Standard
Supplement 5 Manufacturing (CMC) Approved January 24, 1997 Standard
Supplement 1 Manufacturing (CMC) Approved December 18, 1996 Standard
Supplement 3 Manufacturing (CMC) Approved June 28, 1996 Standard
Supplement 2 Manufacturing (CMC) Approved June 27, 1996 Standard
Original application 1 Type 3 - New Dosage Form Approved November 17, 1995 Standard

Review documents

  • 0 · Supplement · April 24, 2025
  • 0 · Supplement · February 20, 2024
  • 0 · Supplement · February 16, 2024
  • 0 · Supplement · November 6, 2017
  • 0 · Supplement · November 3, 2017
  • 0 · Supplement · September 4, 2015
  • 0 · Supplement · September 4, 2015
  • 0 · Supplement · January 24, 2013
  • 0 · Supplement · February 7, 2012
  • 0 · Supplement · February 7, 2012
  • 0 · Supplement · February 7, 2012
  • 0 · Supplement · February 7, 2012
  • 0 · Supplement · February 6, 2012
  • 0 · Supplement · February 6, 2012
  • 0 · Supplement · February 6, 2012
  • 0 · Supplement · February 6, 2012
  • 0 · Supplement · January 7, 2011
  • 0 · Supplement · January 7, 2011
  • 0 · Supplement · January 7, 2011
  • 0 · Supplement · January 6, 2010
  • 0 · Supplement · January 4, 2010
  • 0 · Supplement · June 5, 2009
  • 0 · Original application · June 2, 2009
  • 0 · Supplement · May 26, 2009
  • 0 · Supplement · March 5, 2008
  • 0 · Supplement · March 5, 2008
  • 0 · Supplement · August 4, 2006
  • 0 · Supplement · August 4, 2006
  • 0 · Supplement · July 8, 2005
  • 0 · Supplement · July 7, 2005

Adverse event reports

Source: openFDA FAERS
60,493
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MEDROXYPROGESTERONE ACETATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0046-1105-11 0046-1105 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1 BLISTER PACK in 1 CARTON (0046-1105-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK September 21, 2009
0046-1106-11 0046-1106 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK September 21, 2009
0046-1107-11 0046-1107 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1 BLISTER PACK in 1 CARTON (0046-1107-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK September 21, 2009
0046-1108-11 0046-1108 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 1 BLISTER PACK in 1 CARTON (0046-1108-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACK December 3, 2012
0046-1105 0046-1105 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. — September 21, 2009
0046-1106 0046-1106 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. — September 21, 2009
0046-1107 0046-1107 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. — September 21, 2009
0046-1108 0046-1108 Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. — December 3, 2012

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.