Home NDC 35356-928 Ciprofloxacin
Product NDC 35356-928
11-digit product format 353560928
Labeler code 35356
Product ID 35356-928_2fe367ab-4d42-4412-9cc1-9afb10ab4d43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ciprofloxacin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA075593
Marketing category ANDA
Marketing start 2013-05-02
Marketing end 0000-00-00
Substance CIPROFLOXACIN HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 64 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 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 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 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075593-002 CIPROFLOXACIN HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2004-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075593-003 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 A075593-004 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ciprofloxacin hydrochloride ACTIVE INGREDIENT 4BA73M5E37 CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 CIPROFLOXACIN ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CIPROFLOXACIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] 1