Home NDC 10544-605 Ciprofloxacin
Product NDC 10544-605
11-digit product format 105440605
Labeler code 10544
Product ID 10544-605_2d12d7b7-73ae-41b9-9a03-cecc9f4a5e97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA075817
Marketing category ANDA
Marketing start 2010-05-17
Marketing end 0000-00-00
Substance CIPROFLOXACIN
Active strength 500 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 110 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 A075817-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 A075817-003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 A075817-004 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075817-003 AB
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 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075817-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075817-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075817-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075817-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075817-003 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075817-001 CIPROFLOXACIN HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-06-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075817-002 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2004-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075817-003 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 A075817-004 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL 2004-06-09 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 10544-605-06 Ciprofloxacin 6 in 1 BOTTLE TABLET, FILM COATED 6 1 10544-605-10 Ciprofloxacin 10 in 1 BOTTLE TABLET, FILM COATED 10 1 10544-605-14 Ciprofloxacin 14 in 1 BOTTLE TABLET, FILM COATED 14 1 10544-605-20 Ciprofloxacin 20 in 1 BOTTLE TABLET, FILM COATED 20 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIPROFLOXACIN ACTIVE INGREDIENT 5E8K9I0O4U CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-605 CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 4 package rows 20100826_c14a40f7-6cd7-49c2-9e66-27cbff612257.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-605-06 10544060506 6 in 1 BOTTLE Historical 10544-605-10 10544060510 10 in 1 BOTTLE Historical 10544-605-14 10544060514 14 in 1 BOTTLE Historical 10544-605-20 10544060520 20 in 1 BOTTLE Historical