isoniazid

Product NDC: 46672-866
11-digit product format: 466720866
Labeler code: 46672
Product ID: 46672-866_9c6f946d-8a4a-bf5d-e053-2995a90a42a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isoniazid
Dosage form: TABLET
Route: ORAL
Labeler: Mikart, LLC
Application: ANDA040090
Marketing category: ANDA
Marketing start: 1997-06-26
Marketing end: 0000-00-00
Substance: ISONIAZID
Active strength: 300 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040090-001	ISONIAZID	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26
A040090-002	ISONIAZID	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040090-001	AA
A040090-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA		1997-06-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA		1997-06-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040090-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040090-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040090-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040090-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040090-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040090-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040090-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040090-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040090-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040090-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040090-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040090-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040090-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040090-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040090-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040090-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040090-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040090-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040090-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040090-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040090-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040090-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040090-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040090-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040090-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040090-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040090-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040090-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040090-002	AA	1	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [MIKART, INC.]	1
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [MIKART, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [MIKART, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ISONIAZID TABLET [MIKART, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [MIKART, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ISONIAZID TABLET [MIKART, INC.]	1

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
isoniazid	ISONIAZID	REMEDYREPACK INC.	93252cc8-c8d4-401b-bde5-ca8a3b57651e	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Coupler LLC	44592c5c-d11c-148d-e063-6294a90ab35c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	A-S Medication Solutions	ed780e28-a2c3-44dc-898a-d2cbe05eeedf	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Marlex Pharmaceuticals, Inc.	312cd403-b211-64ef-e063-6394a90aab88	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	OMNIVIUM PHARMACEUTICALS LLC.	35400f1d-fd25-4bfa-a382-ac390e21bf2e	2025-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Bryant Ranch Prepack	eeaf09a3-5631-4089-9f17-15750c002e32	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090
isoniazid	ISONIAZID	Bryant Ranch Prepack	63bf1fe0-5d74-4123-88b7-a95d521befca	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040090 application number: ANDA040090

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
46672-866-03	46672086603	30 TABLET in 1 BOTTLE, PLASTIC (46672-866-03)	30 tablet	1997-06-26	0000-00-00	No	No	Current
46672-866-10	46672086610	100 TABLET in 1 BOTTLE, PLASTIC (46672-866-10)	100 tablet	1997-06-26	0000-00-00	No	No	Current
46672-866-11	46672086611	1000 TABLET in 1 BOTTLE, PLASTIC (46672-866-11)	1000 tablet	1997-06-26	0000-00-00	No	No	Current