Isoniazid

Product NDC: 0440-1655
11-digit product format: 004401655
Labeler code: 0440
Product ID: 0440-1655_fd12cd86-bbb2-4a3d-81e3-6b46e5f11e37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isoniazid
Dosage form: TABLET
Route: ORAL
Labeler: Liberty Pharmaceuticals, Inc.
Application: ANDA080937
Marketing category: ANDA
Marketing start: 1972-09-01
Marketing end: 0000-00-00
Substance: ISONIAZID
Active strength: 300 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0440-1655		I	Inactivated by FDA		2026-08-17
excluded package	package	0440-1655	0440-1655-30	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0440-1655-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0440-1655-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0440-1655-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0440-1655-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0440-1655-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0440-1655-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0440-1655-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0440-1655-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0440-1655-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0440-1655-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0440-1655-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0440-1655-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0440-1655-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0440-1655-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0440-1655-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0440-1655-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0440-1655-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0440-1655-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0440-1655-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0440-1655-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0440-1655-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0440-1655-30	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
A080937-002	ISONIAZID	ISONIAZID	300MG	TABLET / ORAL		Approved before 1982

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	Source SHA-256
2026-08-18 06:07:40	2026-07	A080937-002	ISONIAZID	300MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080937-002	ISONIAZID	300MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080937-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A080937-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080937-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080937-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080937-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080937-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080937-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080937-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080937-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080937-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080937-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080937-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080937-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080937-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080937-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080937-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080937-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080937-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080937-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080937-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080937-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080937-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080937-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080937-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080937-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080937-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080937-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080937-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080937-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080937-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080937-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080937-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080937-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080937-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080937-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080937-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080937-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080937-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080937-002	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
0c158ae5-31fa-5bc4-3cf2-0aa120f1417d	Product name	1	20140508
26abd97e-907b-0cb8-84ee-99fb15297ada	Product name	1	20140508
7cf7f62d-3767-728f-c117-96e96c1ed8bf	Product name	1	20140508
9e3dea0d-7fd5-1a7e-e095-3b9e72f40538	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0440-1655-30	2020-01-31	C162847	48780-1	9d75b9d0-a834-f424-e053-dadaa90a57ce	ISONIAZID TABLETS, USP 100 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0440-1655-30	Isoniazid	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0440-1655-30	EA - Each	0440-1655	9dd2e623-a75d-48ec-bfe7-14f134197e31	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0440-1655	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4	Legacy NDC, 1 package rows	20140403_0013c0c8-513a-48f3-a918-5bc1750c96a7.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoniazid	ISONIAZID	REMEDYREPACK INC.	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Bryant Ranch Prepack	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Bryant Ranch Prepack	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Coupler LLC	38f4c4af-81da-9b0c-e063-6294a90a8b9d	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Genus Lifesciences	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	A-S Medication Solutions	d5039796-6ba0-4fa8-84f7-e47c63d45163	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Mylan Institutional Inc.	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Teva Pharmaceuticals USA, Inc.	9499f1cf-2f46-4047-8b71-90aee7dee854	2021-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Aphena Pharma Solutions - Tennessee, LLC	cb6f5638-2d3a-4334-b272-6b4772d32d03	2020-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937
Isoniazid	ISONIAZID	Proficient Rx LP	65e50989-d24c-4bb3-a041-d6aea2635ef1	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080937 application number: ANDA080937

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V83O1VOZ8L	ISONIAZID	54-85-3	ISONIAZID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197832	isoniazid 300 MG Oral Tablet	PSN	0013c0c8-513a-48f3-a918-5bc1750c96a7	4
197832	isoniazid 300 MG Oral Tablet	SCD	0013c0c8-513a-48f3-a918-5bc1750c96a7	4
197832	INH 300 MG Oral Tablet	SY	0013c0c8-513a-48f3-a918-5bc1750c96a7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0440-1655-30	00440165530	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISONIAZID TABLETS, USP 100 mg and 300 mg	Liberty Pharmaceuticals, Inc.	2013-08-27	HUMAN PRESCRIPTION DRUG LABEL	4