Home NDC 69238-2434 Ciprofloxacin
Product NDC 69238-2434
11-digit product format 692382434
Labeler code 69238
Product ID 69238-2434_d44c6eb1-e419-4bee-977a-b1b46444595f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA075939
Marketing category ANDA
Marketing start 2024-02-29
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 750 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A075939-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 A075939-003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 A075939-004 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09
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 A075939-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075939-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075939-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075939-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075939-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075939-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075939-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075939-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075939-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075939-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 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 A075939-002 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 A075939-003 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 A075939-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075939-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075939-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075939-004 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 A075939-001 CIPROFLOXACIN HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2005-03-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075939-002 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 A075939-003 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 A075939-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ciprofloxacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4BA73M5E37 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197511 Internal RxNorm lookup 197512 Internal RxNorm lookup 309309 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69238-2434-1 Ciprofloxacin 100 in 1 BOTTLE TABLET, FILM COATED 100 3 69238-2434-5 Ciprofloxacin 50 in 1 BOTTLE TABLET, FILM COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2434 CIPROFLOXACIN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 3 Current NDC, 2 package rows 20241210_b996e81b-36ec-4ad7-a7c4-bc6700a06648.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69238-2434-1 69238243401 100 TABLET, FILM COATED in 1 BOTTLE (69238-2434-1) 2024-02-29 No No Current 69238-2434-5 69238243405 50 TABLET, FILM COATED in 1 BOTTLE (69238-2434-5) 2024-02-29 No No Current