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ZEGERID

omeprazole and sodium bicarbonate · Powder, for Suspension

Prescription NDA TE AB 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
ZEGERID
Generic name
omeprazole and sodium bicarbonate
Dosage form
Powder, for Suspension
Route
Oral
Marketing category
NDA · NDA
Labeler
Santarus, Inc..
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
2
Packages
1
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
Omeprazole 20 mg/1 200329 View
Omeprazole 40 mg/1 200329 View
Sodium Bicarbonate 1680 mg/1 1868486 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Powder, for Suspension
Route of administration
Oral
Presentations
3

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
Alkalinizing Activity [MoA] MoA All 12 members
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Proton Pump Inhibitor [EPC] EPC All 74 members
Proton Pump Inhibitors [MoA] MoA All 74 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021636
Application type
NDA · New Drug Application
Approval date
June 15, 2004
Sponsor
SALIX
Products on application
2
Submissions recorded
16
Products approved under application 021636.
Product Trade name Form Strength Ingredient Status TE Flags
021636-001 ZEGERID FOR SUSPENSION OMEPRAZOLE; SODIUM BICARBONATE Discontinued AB RLD
021636-002 ZEGERID FOR SUSPENSION OMEPRAZOLE; SODIUM BICARBONATE Discontinued AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

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 021636.
Type No. Action Status Date Review
Supplement 25 Labeling Approved July 18, 2023 Standard
Supplement 24 Labeling Approved March 4, 2022 Standard
Supplement 22 Labeling Approved November 27, 2020 Standard
Supplement 20 Labeling Approved September 24, 2019 Standard
Supplement 19 Labeling Approved June 7, 2018 Standard
Supplement 17 Labeling Approved October 24, 2016 Standard
Supplement 16 Labeling Approved December 19, 2014 901 Required
Supplement 15 Labeling Approved February 25, 2014 901 Required
Supplement 14 Manufacturing (CMC) Approved December 20, 2013 Standard
Supplement 12 Labeling Approved November 9, 2012 Standard
Supplement 13 Labeling Approved April 19, 2012 Standard
Supplement 11 Labeling Approved December 7, 2011 Unknown
Supplement 10 Labeling Approved May 20, 2011 Unknown
Supplement 9 Labeling Approved September 3, 2010 901 Required
Supplement 8 Labeling Approved January 20, 2010 Standard
Original application 1 Type 3 - New Dosage Form and Type 4 - New Combination Approved June 15, 2004 Standard

Review documents

  • 0 · Supplement · July 20, 2023
  • 0 · Supplement · July 20, 2023
  • 0 · Supplement · July 19, 2023
  • 0 · Supplement · March 11, 2022
  • 0 · Supplement · March 7, 2022
  • 0 · Supplement · November 30, 2020
  • 0 · Supplement · November 30, 2020
  • 0 · Supplement · September 25, 2019
  • 0 · Supplement · September 25, 2019
  • 0 · Supplement · June 14, 2018
  • 0 · Supplement · June 12, 2018
  • 0 · Supplement · October 31, 2016
  • 0 · Supplement · October 26, 2016
  • 0 · Supplement · December 29, 2014
  • 0 · Supplement · December 24, 2014
  • 0 · Supplement · March 4, 2014
  • 0 · Supplement · February 27, 2014
  • 0 · Supplement · November 15, 2012
  • 0 · Supplement · November 14, 2012
  • 0 · Supplement · April 23, 2012
  • 0 · Supplement · April 20, 2012
  • 0 · Original application · December 20, 2011
  • 0 · Supplement · December 13, 2011
  • 0 · Supplement · December 13, 2011
  • 0 · Supplement · May 25, 2011
  • 0 · Supplement · May 25, 2011
  • 0 · Supplement · September 10, 2010
  • 0 · Supplement · September 8, 2010
  • 0 · Supplement · August 5, 2010
  • 0 · Supplement · January 29, 2010

Adverse event reports

Source: openFDA FAERS
448,269
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: OMEPRAZOLE. 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
68012-054-03 68012-054 Santarus, Inc.. 3 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKET June 15, 2014
68012-052 68012-052 Santarus, Inc.. — June 15, 2004
68012-054 68012-054 Santarus, Inc.. — June 15, 2014

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.