Isoniazid

Product NDC: 0527-1109
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

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	0527-1109		D	Discontinued by firm	2026-08-17
excluded package	package	0527-1109	0527-1109-01	D	Discontinued by firm	2026-08-17
excluded package	package	0527-1109	0527-1109-10	D	Discontinued by firm	2026-08-17
excluded package	package	0527-1109	0527-1109-30	D	Discontinued by firm	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 · 48 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	0527-1109-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1109-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1109-01	`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	0527-1109-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1109-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1109-01	`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	0527-1109-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1109-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1109-01	`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	0527-1109-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1109-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1109-01	`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	0527-1109-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1109-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1109-01	`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	0527-1109-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1109-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1109-01	`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	0527-1109-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1109-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1109-01	`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	0527-1109-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1109-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1109-01	`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	0527-1109-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1109-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1109-01	`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	0527-1109-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1109-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0527-1109-01	`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	0527-1109-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1109-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0527-1109-01	`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	0527-1109-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1109-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0527-1109-01	`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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1109-01	EA - Each	0527-1109	cc7da354-7ce0-44d8-89aa-c57c529587b9	1	2013-12-02
0527-1109-10	EA - Each	0527-1109	ccc5ae0a-a90e-495f-a3b7-bd5f88d09103	1	2013-12-02
0527-1109-30	EA - Each	0527-1109	50350557-8c45-4770-b16f-d055b613a03e	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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

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
0527-1109-10	00527110910	1000 TABLET in 1 BOTTLE (0527-1109-10)	1000 tablet	2013-10-10	0000-00-00	No	No	Current
0527-1109-30	00527110930	30 TABLET in 1 BOTTLE (0527-1109-30)	30 tablet	2013-10-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isoniazid Tablets, USP 8415801/0617OS Rx only	American Health Packaging	2019-04-11	HUMAN PRESCRIPTION DRUG LABEL	3
Isoniazid Tablets, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2018-08-22	HUMAN PRESCRIPTION DRUG LABEL	1
Isoniazid Tablets, USP Rx only	Lannett Company, Inc.	2018-03-26	HUMAN PRESCRIPTION DRUG LABEL	12