Diazepam

Product NDC: 11704-600
11-digit product format: 117040600
Labeler code: 11704
Product ID: 11704-600_9e08d47f-b706-44b2-9e2f-9ca972592050
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Meridian Medical Technologies LLC
Application: NDA020124
Marketing category: NDA
Marketing start: 1990-12-05
Substance: DIAZEPAM
Active strength: 10 mg/2mL
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
N020124-001	DIAZEPAM	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION			1990-12-05

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020124-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION	1990-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020124-001	DIAZEPAM	5MG/ML	INJECTABLE / INJECTION	1990-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	1990-12-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020124-001	DIAZEPAM	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	1990-12-05	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	10 mg/2mL

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
1807452	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
fa352464-14c8-49e9-b8b7-5a968b1cfa93	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
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
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
11704-600-01	Diazepam	2 mL in 1 SYRINGE, GLASS	INJECTION	2		11
11704-600-01	Diazepam	1 in 1 POUCH	INJECTION	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11704-600-01	ML - Milliliter	11704-600	182d6daf-098d-46a1-9f4e-74d24a239e04	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diazepam	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Diazepam	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Ethanol	INACTIVE INGREDIENT	3K9958V90M	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Nitrogen	INACTIVE INGREDIENT	N762921K75	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	DIAZEPAM INJECTION [U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (MCMR-RCQ-HR)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11704-600	DIAZEPAM INJECTION [MERIDIAN MEDICAL TECHNOLOGIES LLC]	11	Current NDC, Legacy NDC, 2 package rows	20231222_fa352464-14c8-49e9-b8b7-5a968b1cfa93.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
Diazepam	DIAZEPAM	Meridian Medical Technologies LLC	fa352464-14c8-49e9-b8b7-5a968b1cfa93	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020124 application number: NDA020124 ndc (product): 11704-600

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
1807452	diazePAM 10 MG in 2 ML Auto-injector	PSN	fa352464-14c8-49e9-b8b7-5a968b1cfa93	11
1807452	2 ML diazepam 5 MG/ML Auto-Injector	SCD	fa352464-14c8-49e9-b8b7-5a968b1cfa93	11
1807452	diazepam 10 MG per 2 ML Auto-injector	SY	fa352464-14c8-49e9-b8b7-5a968b1cfa93	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11704-600-01	11704060001	1 SYRINGE, GLASS in 1 POUCH (11704-600-01) / 2 mL in 1 SYRINGE, GLASS	1990-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIAZEPAM AUTOINJECTOR C-IV	Meridian Medical Technologies LLC	2023-12-18	HUMAN PRESCRIPTION DRUG LABEL	11