OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Cipro

ciprofloxacin hydrochloride · Tablet, Film Coated

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
Cipro
Generic name
ciprofloxacin hydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
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
Ciprofloxacin Hydrochloride 250 mg/1 309309 View
Ciprofloxacin Hydrochloride 500 mg/1 309309 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
4

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
Cytochrome P450 1A2 Inhibitors [MoA] MoA All 31 members
Fluoroquinolone Antibacterial [EPC] EPC All 20 members
Fluoroquinolones [CS] CS All 20 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
019537
Application type
NDA · New Drug Application
Approval date
October 22, 1987
Sponsor
BAYER HLTHCARE
Products on application
3
Submissions recorded
56
Products approved under application 019537.
Product Trade name Form Strength Ingredient Status TE Flags
019537-002 CIPRO TABLET CIPROFLOXACIN HYDROCHLORIDE Prescription AB RLD
019537-003 CIPRO TABLET CIPROFLOXACIN HYDROCHLORIDE Prescription AB RLD RS
019537-004 CIPRO TABLET CIPROFLOXACIN HYDROCHLORIDE Discontinued — RLD

Therapeutic equivalence

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

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 019537.
Type No. Action Status Date Review
Supplement 95 Labeling Approved September 20, 2024 Standard
Supplement 92 Labeling Approved November 11, 2021 Standard
Supplement 93 Labeling Approved March 30, 2021 Standard
Supplement 91 Labeling Approved May 8, 2020 Standard
Supplement 90 Labeling Approved March 5, 2020 Standard
Supplement 89 Labeling Approved May 3, 2019 Standard
Supplement 88 Labeling Approved October 18, 2018 Standard
Supplement 87 Labeling Approved July 26, 2017 Standard
Supplement 85 Labeling Approved September 14, 2016 Standard
Supplement 86 Labeling Approved July 26, 2016 Standard
Supplement 83 Efficacy Approved February 2, 2015 Standard
Supplement 82 Labeling Approved August 14, 2013 901 Required
Supplement 81 Labeling Approved January 30, 2013 Standard
Supplement 74 Labeling Approved November 15, 2011 Unknown
Supplement 80 Labeling Approved October 18, 2011 Unknown
Supplement 79 REMS Approved August 3, 2011 N/A
Supplement 78 Labeling Approved June 10, 2011 Unknown
Supplement 75 Labeling Approved February 25, 2011 901 Required
Supplement 71 Labeling Approved June 24, 2009 Standard
Supplement 70 Labeling Approved April 27, 2009 Standard
Supplement 73 Labeling Approved April 6, 2009 Standard
Supplement 69 Labeling Approved February 13, 2009 Standard
Supplement 68 Labeling Approved October 3, 2008 Standard
Supplement 67 Labeling Approved January 18, 2008 Standard
Supplement 65 Labeling Approved June 25, 2007 Standard
Supplement 62 Labeling Approved June 19, 2006 Standard
Supplement 60 Labeling Approved November 9, 2005 Standard
Supplement 57 Labeling Approved May 18, 2005 Standard
Supplement 52 Efficacy Approved January 7, 2005 Unknown
Supplement 54 Labeling Approved July 14, 2004 Standard
Supplement 53 Labeling Approved July 14, 2004 Standard
Supplement 49 Efficacy Approved March 25, 2004 Priority
Supplement 51 Labeling Approved March 15, 2004 Standard
Supplement 50 Labeling Approved March 15, 2004 Standard
Supplement 48 Labeling Approved March 15, 2004 Standard
Supplement 41 Labeling Approved April 17, 2002 Standard
Supplement 38 Efficacy Approved August 30, 2000 Priority
Supplement 40 Labeling Approved June 28, 2000 Standard
Supplement 39 Labeling Approved June 28, 2000 Standard
Supplement 36 Labeling Approved June 28, 2000 Standard
Supplement 34 Labeling Approved June 28, 2000 Standard
Supplement 33 Labeling Approved September 17, 1998 Standard
Supplement 31 Labeling Approved September 17, 1998 Standard
Supplement 30 Labeling Approved September 17, 1998 Standard
Supplement 27 Efficacy Approved April 3, 1998 Unknown
Supplement 25 Labeling Approved September 26, 1997 Standard
Supplement 29 Efficacy Approved June 3, 1997 Unknown
Supplement 16 Efficacy Approved May 15, 1997 —
Supplement 28 Labeling Approved November 22, 1996 Standard
Supplement 22 Efficacy Approved October 10, 1996 Unknown
Supplement 21 Efficacy Approved September 11, 1996 Standard
Supplement 19 Efficacy Approved September 13, 1995 Unknown
Supplement 15 Efficacy Approved July 21, 1994 —
Supplement 13 Efficacy Approved July 21, 1994 —
Supplement 8 Labeling Approved January 22, 1993 —
Original application 1 Type 1 - New Molecular Entity Approved October 22, 1987 Priority

Review documents

  • 0 · Supplement · September 24, 2024
  • 0 · Supplement · September 23, 2024
  • 0 · Supplement · September 23, 2024

Adverse event reports

Source: openFDA FAERS
96,908
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: CIPROFLOXACIN HYDROCHLORIDE. 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
50419-754-01 50419-754 Bayer HealthCare Pharmaceuticals Inc. 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01) October 22, 1987
50419-758-01 50419-758 Bayer HealthCare Pharmaceuticals Inc. 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01) October 22, 1987
50419-754 50419-754 Bayer HealthCare Pharmaceuticals Inc. — October 22, 1987
50419-758 50419-758 Bayer HealthCare Pharmaceuticals Inc. — October 22, 1987

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.