Home NDC 75834-112 OFLOXACIN
Product NDC 75834-112
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 1 .
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 · 123 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 2026-02-19 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OFLOXACIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OFLOXACIN 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A4P49JAZ9H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198048 Internal RxNorm lookup 198049 Internal RxNorm lookup 198050 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OFLOXACIN OFLOXACIN Modavar Pharmaceuticals LLC 93ed9f70-b44f-496b-bdfc-c1bd5f1c260b 2026-06-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091656 application number: ANDA091656 OFLOXACIN OFLOXACIN Cadila Pharmaceuticals Limited c677b35c-0432-4ee5-af57-1f95449c48b6 2024-09-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091656 application number: ANDA091656 OFLOXACIN OFLOXACIN Nivagen Pharmaceuticals, Inc. 1779c568-d7bb-4bd5-bc29-13bd52ba8a0a 2023-07-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091656 application number: ANDA091656 OFLOXACIN OFLOXACIN Nivagen Pharmaceuticals, Inc. ee1bf431-97fa-4aba-9cc3-0cfcea779ca2 2022-02-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091656 application number: ANDA091656 ndc (product): 75834-112
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 75834-112-01 75834011201 100 TABLET, COATED in 1 BOTTLE (75834-112-01) 2016-07-15 0000-00-00 No No Current 75834-112-05 75834011205 500 TABLET, COATED in 1 BOTTLE (75834-112-05) 2016-07-15 0000-00-00 No No Current 75834-112-50 75834011250 50 TABLET, COATED in 1 BOTTLE (75834-112-50) 2016-07-15 0000-00-00 No No Current