Home NDC 63629-1326 Ciprofloxacin
Product NDC 63629-1326
11-digit product format 636291326
Labeler code 63629
Product ID 63629-1326_ff7bf21e-6ea9-4c1d-8448-3dda03f772e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075593
Marketing category ANDA
Marketing start 2004-06-09
Marketing end 0000-00-00
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075593-001 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 A075593-003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 A075593-004 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG 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 5 · 162 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 2026-10-15 13:18:30 2026-09 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075593-003 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075593-003 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075593-003 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075593-003 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075593-003 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075593-001 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075593-003 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075593-001 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 · 156 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIPROFLOXACIN HYDROCHLORIDE ACTIVE INGREDIENT 4BA73M5E37 CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1004
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-1326 CIPROFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] 1011 Legacy NDC 20240514_ff7bf21e-6ea9-4c1d-8448-3dda03f772e9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-1326-0 63629132600 7 TABLET, FILM COATED in 1 BOTTLE (63629-1326-0) 2005-06-28 0000-00-00 No No Current 63629-1326-1 63629132601 20 TABLET, FILM COATED in 1 BOTTLE (63629-1326-1) 2008-01-16 0000-00-00 No No Current 63629-1326-2 63629132602 10 TABLET, FILM COATED in 1 BOTTLE (63629-1326-2) 2008-01-16 0000-00-00 No No Current 63629-1326-3 63629132603 14 TABLET, FILM COATED in 1 BOTTLE (63629-1326-3) 2008-01-16 0000-00-00 No No Current 63629-1326-4 63629132604 6 TABLET, FILM COATED in 1 BOTTLE (63629-1326-4) 2008-01-16 0000-00-00 No No Current 63629-1326-5 63629132605 30 TABLET, FILM COATED in 1 BOTTLE (63629-1326-5) 2008-01-16 0000-00-00 No No Current 63629-1326-6 63629132606 60 TABLET, FILM COATED in 1 BOTTLE (63629-1326-6) 2008-01-16 0000-00-00 No No Current 63629-1326-7 63629132607 12 TABLET, FILM COATED in 1 BOTTLE (63629-1326-7) 2008-01-16 0000-00-00 No No Current 63629-1326-8 63629132608 40 TABLET, FILM COATED in 1 BOTTLE (63629-1326-8) 2008-01-16 0000-00-00 No No Current 63629-1326-9 63629132609 90 TABLET, FILM COATED in 1 BOTTLE (63629-1326-9) 2008-01-16 0000-00-00 No No Current