Home NDC 71209-099 OFLOXACIN
Product NDC 71209-099
11-digit product format 712090099
Labeler code 71209
Product ID 71209-099_85ff09b7-6b73-44bd-a654-11fbab9efdbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OFLOXACIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA091656
Marketing category ANDA
Marketing start 2015-12-29
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.
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 2026-08-01 22:54:32 2026-06 A091656-001 OFLOXACIN 200MG TABLET / ORAL AB 2014-09-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A091656-002 OFLOXACIN 300MG TABLET / ORAL AB 2014-09-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A091656-003 OFLOXACIN 400MG TABLET / ORAL AB 2014-09-18 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 71209-099 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
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71209-099-02 OFLOXACIN 100 in 1 BOTTLE TABLET, FILM COATED 100 15 71209-099-05 OFLOXACIN 500 in 1 BOTTLE TABLET, FILM COATED 500 15 71209-099-10 OFLOXACIN 50 in 1 BOTTLE TABLET, FILM COATED 50 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-099 OFLOXACIN TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] 15 Current NDC, Legacy NDC, 3 package rows 20240920_c677b35c-0432-4ee5-af57-1f95449c48b6.zip
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 71209-099-02 71209009902 100 TABLET, FILM COATED in 1 BOTTLE (71209-099-02) 2015-12-29 0000-00-00 No No Current 71209-099-05 71209009905 500 TABLET, FILM COATED in 1 BOTTLE (71209-099-05) 2015-12-29 0000-00-00 No No Current 71209-099-10 71209009910 50 TABLET, FILM COATED in 1 BOTTLE (71209-099-10) 2015-12-29 0000-00-00 No No Current