Home NDC 50090-1490-0 Isoniazid
Product NDC 50090-1490
Requested package NDC 50090-1490-0
11-digit product format 500901490
Labeler code 50090
Product ID 50090-1490_8cf701e6-6d8f-49a1-a244-c92874e2635e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name isoniazid
Dosage form SOLUTION
Route ORAL
Labeler A-S Medication Solutions
Application ANDA088235
Marketing category ANDA
Marketing start 1983-11-11
Marketing end 0000-00-00
Substance ISONIAZID
Active strength 50 mg/5mL
Pharmacologic classes Antimycobacterial [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A088235-001 ISONIAZID ISONIAZID 50MG/5ML SYRUP / ORAL AA RLD, RS 1983-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088235-001 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 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA RLD, RS 1983-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA RLD, RS 1983-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA RLD, RS 1983-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA RLD, RS 1983-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL AA RLD, RS 1983-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RS 1983-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088235-001 ISONIAZID 50MG/5ML SYRUP / ORAL RLD, RS 1983-11-10 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1490-0 Isoniazid 473 mL in 1 BOTTLE SOLUTION 473 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1490 ISONIAZID SOLUTION [A-S MEDICATION SOLUTIONS] 10 Legacy NDC, 1 package rows 20210224_fada0e39-68f7-434d-91fc-84a67fc940f9.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 CMP Pharma, Inc. db8a3ae7-fb5b-47a9-a9f7-f57cd90501c2 2024-11-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 088235 application number: ANDA088235
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 50090-1490-0 50090149000 473 mL in 1 BOTTLE (50090-1490-0) 473 ml 2014-12-04 0000-00-00 No No Current