Home NDC 75834-112-05 OFLOXACIN
Product NDC 75834-112
Requested package NDC 75834-112-05
11-digit product format 758340112
Labeler code 75834
Product ID 75834-112_67a823b3-3e2d-4483-98e5-99fbddc0c8f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OFLOXACIN
Dosage form TABLET, COATED
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA091656
Marketing category ANDA
Marketing start 2016-07-15
Substance OFLOXACIN
Active strength 400 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC], Quinolones [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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091656-001 OFLOXACIN OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 A091656-002 OFLOXACIN OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 A091656-003 OFLOXACIN OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18
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 · 129 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 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 75834-112-01 2022-02-15 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-05 2022-02-15 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-50 2022-02-15 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-01 2022-01-28 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-05 2022-01-28 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-50 2022-01-28 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-01 2020-05-06 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-05 2020-05-06 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-50 2020-05-06 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-01 2020-01-31 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-05 2020-01-31 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc. 75834-112-50 2020-01-31 OFLOXACIN - ofloxacin tablet, USP film coated Nivagen Pharmaceuticals, Inc.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-112-01 OFLOXACIN 100 in 1 BOTTLE TABLET, COATED 100 4 75834-112-05 OFLOXACIN 500 in 1 BOTTLE TABLET, COATED 500 4 75834-112-50 OFLOXACIN 50 in 1 BOTTLE TABLET, COATED 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-112 OFLOXACIN TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20220216_ee1bf431-97fa-4aba-9cc3-0cfcea779ca2.zip
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 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 75834-112-05 75834011205 500 TABLET, COATED in 1 BOTTLE (75834-112-05) 2016-07-15 0000-00-00 No No Current