Home NDC 0527-1109-01 Isoniazid
Product NDC 0527-1109
Requested package NDC 0527-1109-01
11-digit product format 005271109
Labeler code 0527
Product ID 0527-1109_a13b95af-4c61-4f51-ad02-7e6d470756e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isoniazid
Dosage form TABLET
Route ORAL; ORAL
Labeler Lannett Company, Inc.
Application ANDA089776
Marketing category ANDA
Marketing start 2013-10-10
Marketing end 0000-00-00
Substance ISONIAZID
Active strength 300 mg/1
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISONIAZID ACTIVE INGREDIENT V83O1VOZ8L ISONIAZID TABLET [LANNETT COMPANY, INC.] 6 ISONIAZID ACTIVE MOIETY V83O1VOZ8L ISONIAZID TABLET [LANNETT COMPANY, INC.] 6 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L ISONIAZID TABLET [LANNETT COMPANY, INC.] 6 CALCIUM SULFATE DIHYDRATE INACTIVE INGREDIENT 4846Q921YM ISONIAZID TABLET [LANNETT COMPANY, INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ISONIAZID TABLET [LANNETT COMPANY, INC.] 6 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ ISONIAZID TABLET [LANNETT COMPANY, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ISONIAZID TABLET [LANNETT COMPANY, INC.] 6
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 2e09b1a5-9786-427f-bf00-be15b06eb7e7 2025-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 089776 application number: ANDA089776
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-1109-01 00527110901 100 TABLET in 1 BOTTLE (0527-1109-01) 100 tablet 2013-10-10 0000-00-00 No No Current