Diazepam

Product NDC: 62332-811
Requested package NDC: 62332-811-20
11-digit product format: 623320811
Labeler code: 62332
Product ID: 62332-811_3779694b-e1cc-44ec-92c3-3299d3734bee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA218450
Marketing category: ANDA
Marketing start: 2024-04-25
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 43.

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
A218450-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2024-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218450-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218450-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218450-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218450-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218450-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218450-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218450-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218450-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218450-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218450-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218450-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218450-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218450-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218450-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218450-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218450-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218450-001	AP	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218450-001	AP	1	`a50c72e98297…`

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: 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
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
6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	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
62332-811-02	Diazepam	2 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	2		4
62332-811-20	Diazepam	10 in 1 CARTON	INJECTION, SOLUTION	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62332-811-02	ML - Milliliter	62332-811	a3ecc29f-9e07-4ba5-acd3-4caf48d9f9f8	1	2024-08-12
62332-811-20	ML - Milliliter	62332-811	2268a716-724a-42b1-b090-6c6c56dc1074	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-811	DIAZEPAM INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.]	4	Current NDC, 2 package rows	20240501_6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	b4a045e4-d6ce-475d-abe4-590941bd3815	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450
Diazepam	DIAZEPAM	Sagent Pharmaceuticals	7a912f1a-deee-46df-a8df-22a0afb06529	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450
Diazepam	DIAZEPAM	Alembic Pharmaceuticals Inc.	6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450 ndc (package): 62332-811-20 ndc (product): 62332-811 ndc11 (package): 62332081120
Diazepam	DIAZEPAM	Alembic Pharmaceuticals Limited	1632f040-3b2c-43da-a42f-f2baf5ec778a	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450

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	6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	4
2120550	2 ML diazepam 5 MG/ML Prefilled Syringe	SCD	6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	4
2120550	diazepam 10 MG per 2 ML Prefilled Syringe	SY	6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62332-811-20	62332081120	10 SYRINGE, GLASS in 1 CARTON (62332-811-20) / 2 mL in 1 SYRINGE, GLASS (62332-811-02)	2024-04-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	1
Diazepam - Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited (F3)	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited (F3)	2024-04-29	Human Prescription Drug Label	4