Isoniazid

Product NDC: 10135-584
11-digit product format: 101350584
Labeler code: 10135
Product ID: 10135-584_f8a56779-f03a-45a6-a237-7a55a7c149a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isoniazid
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA089776
Marketing category: ANDA
Marketing start: 2014-10-01
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-584		I	Inactivated by FDA	2026-08-17
excluded package	package	10135-584	10135-584-01	I	Inactivated by FDA	2026-08-17
excluded package	package	10135-584	10135-584-10	I	Inactivated by FDA	2026-08-17
excluded package	package	10135-584	10135-584-30	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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-584-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-584-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-584-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-584-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-584-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-584-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-584-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-584-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-584-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-584-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-584-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-584-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-584-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-584-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-584-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-584-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-584-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-584-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-584-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-584-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-584-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-584-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-584-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-584-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-584-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-584-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-584-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-584-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-584-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-584-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-584-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-584-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-584-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-584-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-584-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-584-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-584-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-584-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-584-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-584-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-584-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-584-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-584-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-584-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-584-01	`1332a3947898…`	`d4bfe170f9cd…`

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	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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
10135-584-01	2020-01-31	C162847	48780-1	9d75b9cf-dae7-f424-e053-dadaa90a57ce	Isoniazid Tablet
10135-584-10	2020-01-31	C162847	48780-1	9d75b9cf-dae7-f424-e053-dadaa90a57ce	Isoniazid Tablet
10135-584-30	2020-01-31	C162847	48780-1	9d75b9cf-dae7-f424-e053-dadaa90a57ce	Isoniazid Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-584-01	Isoniazid	100 in 1 BOTTLE, PLASTIC	TABLET	100	1
10135-584-10	Isoniazid	1000 in 1 BOTTLE	TABLET	1000	1
10135-584-30	Isoniazid	30 in 1 BOTTLE	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-584-01	EA - Each	10135-584	e0e8b957-1011-4638-a96c-6ca202538472	1	2016-03-04
10135-584-30	EA - Each	10135-584	15e4bbe7-45ba-4569-b6f7-9636e64a14c3	1	2016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-584	ISONIAZID TABLET [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 3 package rows	20160210_b9e6aa9e-c905-4774-b4d4-ae6acc2f64a1.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

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	b9e6aa9e-c905-4774-b4d4-ae6acc2f64a1	1
197832	isoniazid 300 MG Oral Tablet	SCD	b9e6aa9e-c905-4774-b4d4-ae6acc2f64a1	1
197832	INH 300 MG Oral Tablet	SY	b9e6aa9e-c905-4774-b4d4-ae6acc2f64a1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-584-01	10135058401	100 in 1 BOTTLE, PLASTIC	Historical
10135-584-10	10135058410	1000 in 1 BOTTLE	Historical
10135-584-30	10135058430	30 in 1 BOTTLE	Historical