Isoniazid

Product NDC: 64950-217
11-digit product format: 649500217
Labeler code: 64950
Product ID: 64950-217_6ea58bc8-a5a8-47a1-81e1-f769924e1502
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isoniazid
Dosage form: TABLET
Route: ORAL
Labeler: Genus Lifesciences
Application: ANDA080937
Marketing category: ANDA
Marketing start: 2024-11-01
Marketing end: 2028-02-28
Substance: ISONIAZID
Active strength: 300 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Isoniazid

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISONIAZID	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V83O1VOZ8L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197832	Internal RxNorm lookup
311166	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f0b46d1d-2300-457d-a7bd-a88a3f8d2235	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64950-217-03	Isoniazid	30 in 1 BOTTLE	TABLET	30		4
64950-217-10	Isoniazid	100 in 1 BOTTLE	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-217-03	EA - Each	64950-217	e4390e2e-7194-4433-8e9e-48eba1c5d999	1	2024-12-10
64950-217-10	EA - Each	64950-217	85bdf0f0-4a64-4dad-aa70-25c79f7c843d	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64950-217	ISONIAZID TABLET [GENUS LIFESCIENCES]	3	Current NDC, 2 package rows	20250331_f0b46d1d-2300-457d-a7bd-a88a3f8d2235.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 ndc (product): 64950-217
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	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	101
197832	isoniazid 300 MG Oral Tablet	SCD	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	101
197832	INH 300 MG Oral Tablet	SY	9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c	101
197832	isoniazid 300 MG Oral Tablet	PSN	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	6
197832	isoniazid 300 MG Oral Tablet	SCD	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	6
197832	INH 300 MG Oral Tablet	SY	6dab7b7b-a3a9-47ef-b423-134bc6970d8b	6
311166	isoniazid 100 MG Oral Tablet	PSN	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	4
197832	isoniazid 300 MG Oral Tablet	PSN	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	4
311166	isoniazid 100 MG Oral Tablet	SCD	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	4
197832	isoniazid 300 MG Oral Tablet	SCD	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	4
311166	INH 100 MG Oral Tablet	SY	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	4
197832	INH 300 MG Oral Tablet	SY	f0b46d1d-2300-457d-a7bd-a88a3f8d2235	4
197832	isoniazid 300 MG Oral Tablet	PSN	38f4c4af-81da-9b0c-e063-6294a90a8b9d	1
197832	isoniazid 300 MG Oral Tablet	PSN	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	1
197832	isoniazid 300 MG Oral Tablet	SCD	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	1
197832	isoniazid 300 MG Oral Tablet	SCD	38f4c4af-81da-9b0c-e063-6294a90a8b9d	1
197832	INH 300 MG Oral Tablet	SY	b6d6dccc-2577-4bbb-896e-5f75b65ee6ca	1
197832	INH 300 MG Oral Tablet	SY	38f4c4af-81da-9b0c-e063-6294a90a8b9d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64950-217-03	64950021703	30 TABLET in 1 BOTTLE (64950-217-03)	30 tablet	2024-11-01	2027-12-31	No	No	Historical
64950-217-10	64950021710	100 TABLET in 1 BOTTLE (64950-217-10)	100 tablet	2024-11-01	2028-02-28	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isoniazid Tablets, USP	REMEDYREPACK INC.	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	6
Isoniazid Tablets, USP	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1
Isoniazid Tablets, USP	Bryant Ranch Prepack	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	101
Isoniazid Tablets, USP	Coupler LLC	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Isoniazid Tablets, USP	Genus Lifesciences	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	4