Diazepam

Product NDC: 0904-7117
11-digit product format: 009047117
Labeler code: 0904
Product ID: 0904-7117_0a512abe-88ed-49f6-99b2-246f6d18681b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA070928
Marketing category: ANDA
Marketing start: 1987-04-03
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 5 mg/5mL
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-7117		D	Discontinued by firm		2026-08-10
excluded package	package	0904-7117	0904-7117-93	D	Discontinued by firm		2026-08-10

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
A070928-001	DIAZEPAM	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070928-001	AA

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	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070928-001	DIAZEPAM	5MG/5ML	SOLUTION / ORAL	AA	RS	1987-04-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070928-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070928-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070928-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070928-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070928-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070928-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070928-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070928-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070928-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070928-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070928-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070928-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070928-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070928-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070928-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070928-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070928-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070928-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070928-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070928-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070928-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070928-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070928-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070928-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070928-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070928-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070928-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070928-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070928-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070928-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070928-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070928-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070928-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070928-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070928-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070928-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070928-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070928-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070928-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070928-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7117-41	ML - Milliliter	0904-7117	d77d0c18-7586-44ae-b01b-f6903b5b061f	1	2022-06-06
0904-7117-93	ML - Milliliter	0904-7117	2136db42-d78a-4b8d-aa25-ee1eb4950d79	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7117	DIAZEPAM SOLUTION [MAJOR PHARMACEUTICALS]	3	Legacy NDC	20250316_0a512abe-88ed-49f6-99b2-246f6d18681b.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	Precision Dose Inc.	78d5a77d-5ca7-4f16-b4d0-fce86456593c	2025-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	Hikma Pharmaceuticals USA Inc.	9e85abed-1a8b-4762-a31f-f2c7f196b8af	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	American Health Packaging	aeadf0b0-918b-40e0-a5e8-60b2fcbd5ded	2023-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928
Diazepam	DIAZEPAM	Pharmaceutical Associates, Inc.	b24f1eb7-3dab-4183-b81f-f86ac62aedd8	2021-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070928 application number: ANDA070928

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
0904-7117-93	00904711793	30 CUP, UNIT-DOSE in 1 CASE (0904-7117-93) > 5 mL in 1 CUP, UNIT-DOSE (0904-7117-41)	1987-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Oral Solution, CIV, 5 mg per 5 mL Rx Only	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	3