isoniazid

Product NDC: 10135-804
11-digit product format: 101350804
Labeler code: 10135
Product ID: 10135-804_3e871908-abb7-9d35-e063-6394a90ac63d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isoniazid
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals, Inc.
Application: ANDA040090
Marketing category: ANDA
Marketing start: 2025-03-01
Substance: ISONIAZID
Active strength: 100 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040090-001	ISONIAZID	100MG	TABLET / ORAL	AA	RS	1997-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040090-002	ISONIAZID	300MG	TABLET / ORAL	AA	RS	1997-06-26	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040090-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040090-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040090-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040090-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040090-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040090-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040090-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040090-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040090-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040090-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040090-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040090-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040090-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040090-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040090-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040090-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040090-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040090-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040090-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040090-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040090-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040090-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040090-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040090-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040090-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040090-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040090-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040090-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040090-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040090-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040090-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040090-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040090-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040090-002	AA	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: isoniazid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISONIAZID	100 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
312cd403-b211-64ef-e063-6394a90aab88	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
10135-804-01	isoniazid	100 in 1 BOTTLE, PLASTIC	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-804-01	EA - Each	10135-804	b2299530-3943-4159-928d-6df936b4a06d	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-804	ISONIAZID TABLET [MARLEX PHARMACEUTICALS, INC.]	2	Current NDC, 1 package rows	20250406_312cd403-b211-64ef-e063-6394a90aab88.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 · 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 ndc (product): 10135-804
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311166	isoniazid 100 MG Oral Tablet	PSN	312cd403-b211-64ef-e063-6394a90aab88	3
197832	isoniazid 300 MG Oral Tablet	PSN	312cd403-b211-64ef-e063-6394a90aab88	3
311166	isoniazid 100 MG Oral Tablet	SCD	312cd403-b211-64ef-e063-6394a90aab88	3
197832	isoniazid 300 MG Oral Tablet	SCD	312cd403-b211-64ef-e063-6394a90aab88	3
311166	INH 100 MG Oral Tablet	SY	312cd403-b211-64ef-e063-6394a90aab88	3
197832	INH 300 MG Oral Tablet	SY	312cd403-b211-64ef-e063-6394a90aab88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10135-804-01	10135080401	100 TABLET in 1 BOTTLE, PLASTIC (10135-804-01)	100 tablet	2025-03-01	No	No	Current