DIAZEPAM

Product NDC: 0404-9769
11-digit product format: 004049769
Labeler code: 0404
Product ID: 0404-9769_fac39e0b-2b18-42c7-b8fd-41dbddd999e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA070313
Marketing category: ANDA
Marketing start: 2025-11-18
Substance: DIAZEPAM
Active strength: 5 mg/mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 1.

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
A070313-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1985-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070313-001	AP

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070313-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION		1985-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070313-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	1985-12-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070313-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070313-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070313-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070313-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070313-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070313-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070313-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070313-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070313-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070313-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070313-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070313-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070313-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070313-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070313-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070313-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070313-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A070313-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070313-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070313-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070313-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070313-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070313-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070313-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070313-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070313-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070313-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070313-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070313-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070313-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070313-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070313-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A070313-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3JTX2Q7TU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2120550	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
dcf7bc20-6c57-491a-b9e3-f42bacff8b99	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
69057c52-36b0-21c0-02d6-d697be15c03c	Product name	4	20260305
da74e203-d183-4c62-8511-c3ef56b5964e	Product name	1	20250213
2792dd44-ff30-4712-8b05-1850c2b4d307	Product name	3	20250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876	Product name	2	20250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42b	Product name	2	20240529
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
02ac201d-7ee6-00c9-f963-81bb5a506b68	Product name	3	20160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9769-02	DIAZEPAM	2 mL in 1 SYRINGE	INJECTION	2		1
0404-9769-02	DIAZEPAM	1 in 1 BAG	INJECTION	1		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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIAZEPAM	DIAZEPAM	Henry Schein, Inc.	dcf7bc20-6c57-491a-b9e3-f42bacff8b99	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070313 application number: ANDA070313 ndc (product): 0404-9769
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	2719720b-4918-4f08-b1de-b267f404505f	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070313 application number: ANDA070313

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3JTX2Q7TU	DIAZEPAM	439-14-5	DIAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2120550	diazePAM 10 MG in 2 ML Prefilled Syringe	PSN	dcf7bc20-6c57-491a-b9e3-f42bacff8b99	1
2120550	2 ML diazepam 5 MG/ML Prefilled Syringe	SCD	dcf7bc20-6c57-491a-b9e3-f42bacff8b99	1
2120550	diazepam 10 MG per 2 ML Prefilled Syringe	SY	dcf7bc20-6c57-491a-b9e3-f42bacff8b99	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0404-9769-02	00404976902	1 SYRINGE in 1 BAG (0404-9769-02) / 2 mL in 1 SYRINGE	1 syringe	2025-11-18	No	No	Current