Home NDC 46672-597 isoniazid
Product NDC 46672-597
11-digit product format 466720597
Labeler code 46672
Product ID 46672-597_2757899a-a72a-4820-9b19-37b17d45a19f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isoniazid
Dosage form SYRUP
Route ORAL
Labeler Mikart, LLC
Application ANDA081118
Marketing category ANDA
Marketing start 1997-07-21
Marketing end 0000-00-00
Substance ISONIAZID
Active strength 50 mg/5mL
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A081118-001 ISONIAZID ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081118-001 AA
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 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA 1997-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081118-001 ISONIAZID 50MG/5ML SYRUP / ORAL 1997-07-21 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Isoniazid ISONIAZID Chartwell RX, LLC 8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c 2025-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081118 application number: ANDA081118
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46672-597-16 46672059716 473 mL in 1 BOTTLE (46672-597-16) 473 ml 1997-07-21 0000-00-00 No No Current