Isoniazid

Product NDC: 0555-0071
11-digit product format: 005550071
Labeler code: 0555
Product ID: 0555-0071_ead93989-8a7e-4483-917e-388152515e1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isoniazid
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA080937
Marketing category: ANDA
Marketing start: 1972-09-01
Marketing end: 2027-06-30
Substance: ISONIAZID
Active strength: 300 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Isoniazid

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISONIAZID	300 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	V83O1VOZ8L
Rxcui	197832, 311166

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0555-0071-01	Isoniazid	30 in 1 BOTTLE, UNIT-DOSE	TABLET	30		14
0555-0071-02	Isoniazid	100 in 1 BOTTLE	TABLET	100		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0071-01	EA - Each	0555-0071	97493eb5-03eb-4d9f-aea8-be8e0c855081	1	2012-07-24
0555-0071-02	EA - Each	0555-0071	27467b27-4afd-42cf-896f-5ea8fb086318	1	2012-07-24
0555-0071-05	EA - Each	0555-0071	6b7e8b2b-06be-41c9-98b0-356b40846686	1	2012-07-24

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 INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [BARR LABORATORIES INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]	4
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]	2
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
isoniazid	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID TABLET [STAT RX USA LLC]	1
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
isoniazid	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [STAT RX USA LLC]	1
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ISONIAZID TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0071	ISONIAZID TABLET [TEVA PHARMACEUTICALS USA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20241211_9499f1cf-2f46-4047-8b71-90aee7dee854.zip

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	d5039796-6ba0-4fa8-84f7-e47c63d45163	16
197832	isoniazid 300 MG Oral Tablet	SCD	d5039796-6ba0-4fa8-84f7-e47c63d45163	16
197832	INH 300 MG Oral Tablet	SY	d5039796-6ba0-4fa8-84f7-e47c63d45163	16
311166	isoniazid 100 MG Oral Tablet	PSN	9499f1cf-2f46-4047-8b71-90aee7dee854	14
197832	isoniazid 300 MG Oral Tablet	PSN	9499f1cf-2f46-4047-8b71-90aee7dee854	14
311166	isoniazid 100 MG Oral Tablet	SCD	9499f1cf-2f46-4047-8b71-90aee7dee854	14
197832	isoniazid 300 MG Oral Tablet	SCD	9499f1cf-2f46-4047-8b71-90aee7dee854	14
311166	INH 100 MG Oral Tablet	SY	9499f1cf-2f46-4047-8b71-90aee7dee854	14
197832	INH 300 MG Oral Tablet	SY	9499f1cf-2f46-4047-8b71-90aee7dee854	14
197832	isoniazid 300 MG Oral Tablet	PSN	e199dbfa-6d79-4c20-9984-9cd0c1907510	13
197832	isoniazid 300 MG Oral Tablet	SCD	e199dbfa-6d79-4c20-9984-9cd0c1907510	13
197832	INH 300 MG Oral Tablet	SY	e199dbfa-6d79-4c20-9984-9cd0c1907510	13
197832	isoniazid 300 MG Oral Tablet	PSN	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	11
197832	isoniazid 300 MG Oral Tablet	SCD	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	11
197832	INH 300 MG Oral Tablet	SY	60a6b514-fa7f-4bc7-85b0-e5a14fa56b59	11
197832	isoniazid 300 MG Oral Tablet	PSN	df71204a-9962-4a61-bf72-cd8cfd930fc5	7
197832	isoniazid 300 MG Oral Tablet	SCD	df71204a-9962-4a61-bf72-cd8cfd930fc5	7
197832	INH 300 MG Oral Tablet	SY	df71204a-9962-4a61-bf72-cd8cfd930fc5	7
197832	isoniazid 300 MG Oral Tablet	PSN	d0037303-a025-4dcc-9c24-65bc2b66a010	5
197832	isoniazid 300 MG Oral Tablet	SCD	d0037303-a025-4dcc-9c24-65bc2b66a010	5
197832	INH 300 MG Oral Tablet	SY	d0037303-a025-4dcc-9c24-65bc2b66a010	5
197832	isoniazid 300 MG Oral Tablet	PSN	0013c0c8-513a-48f3-a918-5bc1750c96a7	4
197832	isoniazid 300 MG Oral Tablet	PSN	7e7ae778-d5fc-4a1e-8c2c-553598c1841c	4
197832	isoniazid 300 MG Oral Tablet	SCD	0013c0c8-513a-48f3-a918-5bc1750c96a7	4
197832	isoniazid 300 MG Oral Tablet	SCD	7e7ae778-d5fc-4a1e-8c2c-553598c1841c	4
197832	INH 300 MG Oral Tablet	SY	7e7ae778-d5fc-4a1e-8c2c-553598c1841c	4
197832	INH 300 MG Oral Tablet	SY	0013c0c8-513a-48f3-a918-5bc1750c96a7	4
197832	isoniazid 300 MG Oral Tablet	PSN	65e50989-d24c-4bb3-a041-d6aea2635ef1	3
197832	isoniazid 300 MG Oral Tablet	SCD	65e50989-d24c-4bb3-a041-d6aea2635ef1	3
197832	INH 300 MG Oral Tablet	SY	65e50989-d24c-4bb3-a041-d6aea2635ef1	3
311166	isoniazid 100 MG Oral Tablet	PSN	2b87aa05-8028-1b46-e054-00144ff8d46c	2
197832	isoniazid 300 MG Oral Tablet	PSN	2b87aa05-8028-1b46-e054-00144ff8d46c	2
311166	isoniazid 100 MG Oral Tablet	SCD	2b87aa05-8028-1b46-e054-00144ff8d46c	2
197832	isoniazid 300 MG Oral Tablet	SCD	2b87aa05-8028-1b46-e054-00144ff8d46c	2
311166	INH 100 MG Oral Tablet	SY	2b87aa05-8028-1b46-e054-00144ff8d46c	2
197832	INH 300 MG Oral Tablet	SY	2b87aa05-8028-1b46-e054-00144ff8d46c	2
311166	isoniazid 100 MG Oral Tablet	PSN	63dd70bb-e79b-4fa4-93f1-314440354813	1
197832	isoniazid 300 MG Oral Tablet	PSN	63dd70bb-e79b-4fa4-93f1-314440354813	1
197832	isoniazid 300 MG Oral Tablet	PSN	fdc162f2-67c5-4e36-9832-cf48e05b6ed1	1
197832	isoniazid 300 MG Oral Tablet	PSN	f437618b-43f8-673d-e053-2a95a90ad7ad	1
197832	isoniazid 300 MG Oral Tablet	PSN	cb6f5638-2d3a-4334-b272-6b4772d32d03	1
197832	isoniazid 300 MG Oral Tablet	PSN	42602989-2a6d-4df6-ac41-780c1aa724ae	1
197832	isoniazid 300 MG Oral Tablet	PSN	ec0df56a-7746-45f2-88dc-a975cf48abc9	1
311166	isoniazid 100 MG Oral Tablet	SCD	63dd70bb-e79b-4fa4-93f1-314440354813	1
197832	isoniazid 300 MG Oral Tablet	SCD	f437618b-43f8-673d-e053-2a95a90ad7ad	1
197832	isoniazid 300 MG Oral Tablet	SCD	ec0df56a-7746-45f2-88dc-a975cf48abc9	1
197832	isoniazid 300 MG Oral Tablet	SCD	fdc162f2-67c5-4e36-9832-cf48e05b6ed1	1
197832	isoniazid 300 MG Oral Tablet	SCD	42602989-2a6d-4df6-ac41-780c1aa724ae	1
197832	isoniazid 300 MG Oral Tablet	SCD	cb6f5638-2d3a-4334-b272-6b4772d32d03	1
197832	isoniazid 300 MG Oral Tablet	SCD	63dd70bb-e79b-4fa4-93f1-314440354813	1
311166	INH 100 MG Oral Tablet	SY	63dd70bb-e79b-4fa4-93f1-314440354813	1
197832	INH 300 MG Oral Tablet	SY	42602989-2a6d-4df6-ac41-780c1aa724ae	1
197832	INH 300 MG Oral Tablet	SY	63dd70bb-e79b-4fa4-93f1-314440354813	1
197832	INH 300 MG Oral Tablet	SY	ec0df56a-7746-45f2-88dc-a975cf48abc9	1
197832	INH 300 MG Oral Tablet	SY	f437618b-43f8-673d-e053-2a95a90ad7ad	1
197832	INH 300 MG Oral Tablet	SY	cb6f5638-2d3a-4334-b272-6b4772d32d03	1
197832	INH 300 MG Oral Tablet	SY	fdc162f2-67c5-4e36-9832-cf48e05b6ed1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0071-01	00555007101	30 TABLET in 1 BOTTLE, UNIT-DOSE (0555-0071-01)	30 tablet	1972-09-01	2027-03-31	No	No	Current
0555-0071-02	00555007102	100 TABLET in 1 BOTTLE (0555-0071-02)	100 tablet	1972-09-01	2027-06-30	No	No	Current
0555-0071-05	00555007105	1000 TABLET in 1 BOTTLE (0555-0071-05)	1000 tablet	1972-09-01	2021-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isoniazid Tablets, USP	Preferred Pharmaceuticals, Inc.	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	13
Isoniazid Tablets, USP	A-S Medication Solutions	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	16
Isoniazid Tablets, USP Rx Only 8455301/1022F	American Health Packaging	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	7
Isoniazid Tablets, USP	Mylan Institutional Inc.	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	11
Isoniazid Tablets, USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Isoniazid 300 mg	Health Department, Oklahoma State	2023-02-08	HUMAN PRESCRIPTION DRUG LABEL	1
Isoniazid Tablets USP	Bryant Ranch Prepack	2021-12-16	HUMAN PRESCRIPTION DRUG LABEL	4
Isoniazid Tablets, USP	Teva Pharmaceuticals USA, Inc.	2021-10-31	HUMAN PRESCRIPTION DRUG LABEL	14
Isoniazid Tablets USP	Aphena Pharma Solutions - Tennessee, LLC	2020-03-23	HUMAN PRESCRIPTION DRUG LABEL	1
Isoniazid Tablets USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
ISONIAZID TABLETS, USP 100 mg and 300 mg	Department of State Health Services, Pharmacy Branch	2016-03-11	HUMAN PRESCRIPTION DRUG LABEL	2
Isoniazid 300 MG	Northwind Pharmaceuticals, LLC	2014-07-23	HUMAN PRESCRIPTION DRUG LABEL	1
ISONIAZID TABLETS, USP 100 mg and 300 mg	State of Florida DOH Central Pharmacy	2014-03-04	HUMAN PRESCRIPTION DRUG LABEL	1
ISONIAZID TABLETS, USP 100 mg and 300 mg	Liberty Pharmaceuticals, Inc.	2013-08-27	HUMAN PRESCRIPTION DRUG LABEL	4
ISONIAZID TABLETS, USP 100 mg and 300 mg	Physicians Total Care, Inc.	2013-03-04	HUMAN PRESCRIPTION DRUG LABEL	1
ISONIAZID - STAT RX USA LLC	STAT RX USA LLC	2011-08-25	HUMAN PRESCRIPTION DRUG LABEL	1
ISONIAZID TABLETS, USP	Contract Pharmacy Services-PA	2010-08-02	HUMAN PRESCRIPTION DRUG LABEL	1

Isoniazid

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#