Home NDC 68788-9280-2 ciprofloxacin
Product NDC 68788-9280
Requested package NDC 68788-9280-2
11-digit product format 687889280
Labeler code 68788
Product ID 68788-9280_6aa826f6-94c2-46f9-ac5b-e239a091edb4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ciprofloxacin
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA076639
Marketing category ANDA
Marketing start 2015-01-29
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 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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A076639-001 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 A076639-002 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 A076639-003 CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10
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 · 132 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 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076639-002 CIPROFLOXACIN HYDROCHLORIDE EQ 500MG BASE TABLET / ORAL AB 2004-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076639-003 CIPROFLOXACIN HYDROCHLORIDE EQ 750MG BASE TABLET / ORAL AB 2004-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076639-001 CIPROFLOXACIN HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2004-09-10 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 [PREFERRED PHARMACEUTICALS, INC.] 5 ciprofloxacin ACTIVE MOIETY 5E8K9I0O4U CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R CIPROFLOXACIN TABLET [PREFERRED PHARMACEUTICALS, INC.] 5
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-9280-2 68788928002 20 TABLET in 1 BOTTLE (68788-9280-2) 20 tablet 2015-01-29 0000-00-00 No No Current