Diazepam

Product NDC: 52584-213
Requested package NDC: 52584-213-12
11-digit product format: 525840213
Labeler code: 52584
Product ID: 52584-213_2896ce19-7fc8-4691-9350-b79ab221cc26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: General Injectables and Vaccines, Inc.
Application: ANDA071583
Marketing category: ANDA
Marketing start: 2019-08-27
Marketing end: 2023-10-01
Substance: DIAZEPAM
Active strength: 5 mg/mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-213	52584-213-12	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A071583-001	DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071583-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION		RS	1987-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION		RS	1987-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION		RS	1987-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION		RS	1987-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071583-001	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1987-10-13	`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	A071583-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071583-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071583-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071583-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071583-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071583-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071583-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071583-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071583-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071583-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071583-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071583-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071583-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071583-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071583-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071583-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071583-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A071583-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071583-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071583-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071583-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071583-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071583-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071583-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071583-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071583-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071583-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071583-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071583-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071583-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071583-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071583-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071583-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071583-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071583-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071583-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A071583-001	AP	1	`a50c72e98297…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Diazepam	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]	3
Diazepam	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM INJECTION, SOLUTION [GENERAL INJECTABLES AND VACCINES, INC.]	3

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Hospira, Inc.	7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071583 application number: ANDA071583
Diazepam	DIAZEPAM	Henry Schein, Inc.	bfa85a63-967f-4176-a752-0bafabbaaae3	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071583 application number: ANDA071583
Diazepam	DIAZEPAM	Medical Purchasing Solutions, LLC	c8e979a8-af6b-f0c4-e053-2995a90ae63f	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071583 application number: ANDA071583

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-213-12	52584021312	1 VIAL, MULTI-DOSE in 1 BAG (52584-213-12) > 10 mL in 1 VIAL, MULTI-DOSE	2019-08-27	2023-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIAZEPAM Injection, USP 5mg/mL Fliptop Vial Rx only CIV	General Injectables and Vaccines, Inc.	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	12