Diazepam

Product NDC: 55154-6963
11-digit product format: 551546963
Labeler code: 55154
Product ID: 55154-6963_ee1fc404-6078-4d23-a4e1-9956be272d18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Cardinal Health
Application: ANDA072079
Marketing category: ANDA
Marketing start: 1988-12-20
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 10 mg/2mL
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55154-6963		D	Discontinued by firm	2026-09-14
excluded package	package	55154-6963	55154-6963-5	D	Discontinued by firm	2026-09-14
excluded package	package	55154-6963	55154-6963-8	D	Discontinued by firm	2026-09-14

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6963-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-6963-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-6963-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-6963-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-6963-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-6963-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-6963-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-6963-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-6963-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-6963-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-6963-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-6963-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-6963-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-6963-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-6963-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-6963-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-6963-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-6963-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6963-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-6963-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-6963-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-6963-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-6963-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55154-6963-5	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A072079-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072079-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1988-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION			1988-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1988-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1988-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	RS	1988-12-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072079-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		1988-12-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A072079-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072079-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072079-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072079-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072079-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072079-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072079-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072079-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072079-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072079-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072079-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072079-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072079-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072079-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072079-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072079-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072079-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072079-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072079-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072079-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072079-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072079-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072079-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072079-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072079-001	AP	1	`8869cabd3fbd…`
2019-12-14 00:12 UTC	2019-12	A072079-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072079-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072079-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072079-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072079-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072079-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072079-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072079-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072079-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072079-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072079-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072079-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072079-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072079-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072079-001	AP	1	`e64feba35796…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diazepam	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7
Diazepam	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7
Alcohol	INACTIVE INGREDIENT	3K9958V90M	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	DIAZEPAM INJECTION, SOLUTION [CARDINAL HEALTH]	7

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	Hospira, Inc.	41044928-dd1f-40bf-1fa6-709dff559124	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072079 application number: ANDA072079