Home NDC 71610-108-30 Isoniazid
Product NDC 71610-108
Requested package NDC 71610-108-30
11-digit product format 716100108
Labeler code 71610
Product ID 71610-108_845bc0be-9869-42e8-b501-09b3ddee754d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isoniazid
Dosage form TABLET
Route ORAL; ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
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 2020-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71610-108 71610-108-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71610-108 71610-108-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-108 ISONIAZID TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20180828_9b52e8bf-627a-4e9d-b229-ffe0beb7e090.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.
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 71610-108-30 71610010830 30 TABLET in 1 BOTTLE (71610-108-30) 30 tablet 2018-08-10 0000-00-00 No No Current