Home NDC 71335-3083 Isoniazid
Product NDC 71335-3083
11-digit product format 713353083
Labeler code 71335
Product ID 71335-3083_8a54747c-67c0-42c9-bc36-bea05101c811
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isoniazid
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA080936
Marketing category ANDA
Marketing start 2024-11-01
Marketing end 2027-12-31
Substance ISONIAZID
Active strength 100 mg/1
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080936-001 ISONIAZID ISONIAZID 100MG TABLET / ORAL Approved before 1982
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A080936-001 ISONIAZID 100MG TABLET / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080936-001 ISONIAZID 100MG TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080936-001 ISONIAZID 100MG TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080936-001 ISONIAZID 100MG TABLET / ORAL AA Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A080936-001 ISONIAZID 100MG TABLET / ORAL AA RS, Approved before 1982 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Isoniazid Active Ingredients# Ingredient, Strength table Ingredient Strength ISONIAZID 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V83O1VOZ8L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311166 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 71335-3083-1 Isoniazid 30 in 1 BOTTLE TABLET 30 1
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 Isoniazid ISONIAZID Bryant Ranch Prepack 03bf3bd5-64f9-4491-89fd-96c5c10d0129 2026-02-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 080936 application number: ANDA080936 ndc (product): 71335-3083 Isoniazid ISONIAZID Genus Lifesciences f0b46d1d-2300-457d-a7bd-a88a3f8d2235 2025-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 080936 application number: ANDA080936 Isoniazid ISONIAZID A-S Medication Solutions 8a309582-1bb7-4b21-af43-c38710ac83d5 2023-06-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 080936 application number: ANDA080936 Isoniazid ISONIAZID Teva Pharmaceuticals USA, Inc. 9499f1cf-2f46-4047-8b71-90aee7dee854 2021-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 080936 application number: ANDA080936
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-3083-1 71335308301 30 TABLET in 1 BOTTLE (71335-3083-1) 30 tablet 2026-02-16 2027-12-31 No No Historical