Home NDC 50436-6041 Ciprofloxacin
Product NDC 50436-6041
11-digit product format 504366041
Labeler code 50436
Product ID 50436-6041_0a1819ad-cf70-405a-b3d0-263bc344996d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unit Dose Services
Application ANDA076794
Marketing category ANDA
Marketing start 2004-06-09
Marketing end 0000-00-00
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 500 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 95 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076794-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 A076794-003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 A076794-004 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 159 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076794-001 CIPROFLOXACIN HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2005-02-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076794-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076794-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076794-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 153 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-6041-1 Ciprofloxacin 20 in 1 BOTTLE TABLET, FILM COATED 20 8 50436-6041-2 Ciprofloxacin 14 in 1 BOTTLE TABLET, FILM COATED 14 8 50436-6041-3 Ciprofloxacin 10 in 1 BOTTLE TABLET, FILM COATED 10 8 50436-6041-9 Ciprofloxacin 6 in 1 BOTTLE TABLET, FILM COATED 6 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ciprofloxacin hydrochloride ACTIVE INGREDIENT 4BA73M5E37 CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 ciprofloxacin ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 crospovidone INACTIVE INGREDIENT 68401960MK CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [UNIT DOSE SERVICES] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-6041 CIPROFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES] 8 Legacy NDC, 4 package rows 20170816_084020fe-6571-4fb3-a13e-937615432fe8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ciprofloxacin CIPROFLOXACIN Teva Pharmaceuticals USA, Inc. 3e4402d4-e0d3-9846-3e81-ed46f34137fe 2024-10-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076794 application number: ANDA076794 Ciprofloxacin CIPROFLOXACIN NuCare Pharmaceuticals,Inc. b0136d72-0869-2da0-e053-2995a90af70a 2024-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076794 application number: ANDA076794 Ciprofloxacin CIPROFLOXACIN NuCare Pharmaceuticals,Inc. b064286b-fedc-be68-e053-2995a90aae52 2024-07-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076794 application number: ANDA076794
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-6041-1 50436604101 20 in 1 BOTTLE Historical 50436-6041-2 50436604102 14 in 1 BOTTLE Historical 50436-6041-3 50436604103 10 in 1 BOTTLE Historical 50436-6041-9 50436604109 6 in 1 BOTTLE Historical