Home NDC 68071-3901 Ciprofloxacin
Product NDC 68071-3901
11-digit product format 680713901
Labeler code 68071
Product ID 68071-3901_4120667b-faff-54da-e063-6394a90ace2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofolxacin
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA208921
Marketing category ANDA
Marketing start 2023-10-01
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 250 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208921-001 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 A208921-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208921-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2018-06-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208921-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2018-06-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ciprofloxacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIPROFLOXACIN HYDROCHLORIDE 250 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197511 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 68071-3901-1 Ciprofloxacin 100 in 1 BOTTLE TABLET 100 1
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 3 of 3 · 43 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3901-1 68071390101 100 TABLET in 1 BOTTLE (68071-3901-1) 100 tablet 2025-10-14 No No Current