Isoniazid

Product NDC: 0781-3056
11-digit product format: 007813056
Labeler code: 0781
Product ID: 0781-3056_66f2f4a4-1479-450c-8834-89cd29b08f2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isoniazid
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Sandoz Inc
Application: ANDA040648
Marketing category: ANDA
Marketing start: 2006-01-19
Substance: ISONIAZID
Active strength: 100 mg/mL
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 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
A040648-001	ISONIAZID	ISONIAZID	100MG/ML	INJECTABLE / INJECTION		RS	2005-07-05

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040648-001	ISONIAZID	100MG/ML	INJECTABLE / INJECTION	RS	2005-07-05	`e64feba35796…`

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/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204430	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
77795c31-1cdf-4a20-b4a1-cd15f5b310f1	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
0781-3056-70	Isoniazid	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10		18
0781-3056-70	Isoniazid	1 in 1 CARTON	INJECTION, SOLUTION	1		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3056-70	ML - Milliliter	0781-3056	82eb2676-75c9-41c3-be19-8e0898645a64	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ISONIAZID	ACTIVE INGREDIENT	V83O1VOZ8L	ISONIAZID INJECTION, SOLUTION [SANDOZ INC]	10
ISONIAZID	ACTIVE MOIETY	V83O1VOZ8L	ISONIAZID INJECTION, SOLUTION [SANDOZ INC]	10
CHLOROBUTANOL	INACTIVE INGREDIENT	HM4YQM8WRC	ISONIAZID INJECTION, SOLUTION [SANDOZ INC]	10
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ISONIAZID INJECTION, SOLUTION [SANDOZ INC]	10
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ISONIAZID INJECTION, SOLUTION [SANDOZ INC]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3056	ISONIAZID INJECTION, SOLUTION [SANDOZ INC]	17	Current NDC, Legacy NDC, 2 package rows	20221014_77795c31-1cdf-4a20-b4a1-cd15f5b310f1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoniazid	ISONIAZID	Sandoz Inc	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	2025-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040648 application number: ANDA040648 ndc (product): 0781-3056

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
204430	isoniazid 100 MG/ML Injectable Solution	PSN	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	18
204430	isoniazid 100 MG/ML Injectable Solution	SCD	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	18
204430	INH 100 MG/ML Injectable Solution	SY	77795c31-1cdf-4a20-b4a1-cd15f5b310f1	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3056-70	00781305670	1 VIAL, MULTI-DOSE in 1 CARTON (0781-3056-70) / 10 mL in 1 VIAL, MULTI-DOSE	2006-01-19	0000-00-00	No	No	Current