Diazepam

Product NDC: 68788-8462
11-digit product format: 687888462
Labeler code: 68788
Product ID: 68788-8462_66b8a3e7-24fc-4d11-8855-b9ad94e677c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA070325
Marketing category: ANDA
Marketing start: 2023-06-21
Substance: DIAZEPAM
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070325-001	DIAZEPAM	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04
A070325-002	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04
A070325-003	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A070325-001	AB
A070325-002	AB
A070325-003	AB

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 4 · 123 observed 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
2026-02-19 14:30 UTC	2026-02	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070325-002	DIAZEPAM	2MG	TABLET / ORAL	AB	1985-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070325-003	DIAZEPAM	5MG	TABLET / ORAL	AB	1985-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070325-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1985-09-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A070325-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070325-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070325-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070325-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070325-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070325-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070325-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070325-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070325-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070325-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070325-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070325-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070325-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070325-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070325-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070325-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070325-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070325-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070325-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070325-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070325-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070325-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070325-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070325-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070325-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070325-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070325-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070325-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070325-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070325-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070325-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070325-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070325-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070325-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070325-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070325-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070325-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070325-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070325-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070325-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diazepam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	10 mg/1

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
197589	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
6dcbb5e9-1e8f-4069-9244-adb46356714d	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
68788-8462-2	Diazepam	20 in 1 BOTTLE, PLASTIC	TABLET	20		4
68788-8462-3	Diazepam	30 in 1 BOTTLE, PLASTIC	TABLET	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8462-2	EA - Each	68788-8462	97ce1f18-8857-4d03-85ba-9a6c3e036aba	1	2023-08-08
68788-8462-3	EA - Each	68788-8462	a752e190-1d83-46ca-8f80-d56483d1c8cc	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8462	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20250316_6dcbb5e9-1e8f-4069-9244-adb46356714d.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	Unit Dose Solutions, Inc.	547c2ad4-113c-7771-e063-6394a90a2073	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Cardinal Health 107, LLC	ba953b22-f0cd-4be5-9e0e-178bded88727	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Preferred Pharmaceuticals Inc.	6dcbb5e9-1e8f-4069-9244-adb46356714d	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325 ndc (product): 68788-8462
Diazepam	DIAZEPAM	Preferred Pharmaceuticals Inc.	7646785b-dabc-482d-bf42-06177f00aca2	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Safecor Health, LLC	8b51f4b3-a5e8-4400-b624-ac0c47630c86	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Direct_Rx	181cc7ac-5129-2200-e063-6394a90afd3a	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	A-S Medication Solutions	01f04ee4-fff9-499a-8213-984e16368084	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	c2768add-5e01-4ff4-afa3-230380d59a1f	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Mylan Institutional Inc.	b326c66d-5762-4d16-933c-619fa2088ccd	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Advanced Rx of Tennessee, LLC	2d322c6a-7f7e-1cc4-e063-6294a90a8e2e	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Bryant Ranch Prepack	9424ce71-f04c-4d70-89de-b7858931c53d	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Bryant Ranch Prepack	632d7e96-d32c-45b8-86cf-f18ec2b35485	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Direct_rx	2047f721-6a05-c391-e063-6394a90a4ed7	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf3	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Bryant Ranch Prepack	f2fc6f38-d627-4fb3-9be2-5e119ee7e1e1	2023-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325
Diazepam	DIAZEPAM	Mylan Pharmaceuticals Inc.	c397a9da-862f-4f3f-8109-7d21691de53a	2023-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070325 application number: ANDA070325

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
197589	diazePAM 10 MG Oral Tablet	PSN	6dcbb5e9-1e8f-4069-9244-adb46356714d	4
197589	diazepam 10 MG Oral Tablet	SCD	6dcbb5e9-1e8f-4069-9244-adb46356714d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8462-2	68788846202	20 TABLET in 1 BOTTLE, PLASTIC (68788-8462-2)	20 tablet	2023-06-21	No	No	Current
68788-8462-3	68788846203	30 TABLET in 1 BOTTLE, PLASTIC (68788-8462-3)	30 tablet	2023-06-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Tablets, USP 2 mg, 5 mg and 10 mg Rx only	Preferred Pharmaceuticals Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	4