Home NDC 62135-709 Isoniazid
Product NDC 62135-709
11-digit product format 621350709
Labeler code 62135
Product ID 62135-709_2df7a936-6840-66cc-e063-6294a90ae096
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isoniazid
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA089776
Marketing category ANDA
Marketing start 1988-06-13
Substance ISONIAZID
Active strength 300 mg/1
Pharmacologic classes Antimycobacterial [EPC]
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 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 A089776-001 LANIAZID ISONIAZID 300MG TABLET / ORAL 1988-06-13
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 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089776-001 LANIAZID 300MG TABLET / ORAL AA 1988-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089776-001 LANIAZID 300MG TABLET / ORAL AA 1988-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089776-001 LANIAZID 300MG TABLET / ORAL 1988-06-13 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-09-15 20:21 UTC 2019-09 A089776-001 AA 1 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089776-001 AA 1 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Isoniazid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISONIAZID 300 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 197832 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 62135-709-90 Isoniazid 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-709 ISONIAZID TABLET [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20250215_2e09b1a5-9786-427f-bf00-be15b06eb7e7.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-709-90 62135070990 90 TABLET in 1 BOTTLE (62135-709-90) 90 tablet 2023-10-20 No No Current