Diazepam

Product NDC: 67296-0291
Requested package NDC: 67296-0291-2
11-digit product format: 672960291
Labeler code: 67296
Product ID: 67296-0291_d5fbffb6-b2ad-2ecd-e053-2a95a90af4aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug, Inc.
Application: ANDA071307
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0291	67296-0291-2	I	Inactivated by FDA		2026-08-03

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A071307-001	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	AB		1986-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071307-001	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 2 · 41 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	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071307-001	DIAZEPAM	2MG	TABLET / ORAL	AB	1986-12-10	`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	A071307-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071307-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071307-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071307-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071307-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071307-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071307-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071307-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071307-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071307-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071307-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071307-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071307-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071307-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071307-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071307-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071307-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071307-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071307-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071307-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071307-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071307-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071307-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071307-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071307-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071307-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071307-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071307-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071307-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071307-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071307-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071307-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071307-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071307-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071307-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071307-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071307-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071307-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071307-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071307-001	AB	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0291-2	2024-01-30	C162847	48780-1	1030e365-0cdd-111a-e063-dadaa90a10e2	0bfdf83c-6ae3-09e9-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0291-2	Diazepam	2 in 1 BOTTLE	TABLET	2		22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0291	DIAZEPAM TABLET [REDPHARM DRUG, INC.]	22	Legacy NDC, 1 package rows	20220120_0bfdf83c-6ae3-09e9-e054-00144ff88e88.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	1ad84940-40f7-457a-8ffa-53e1a7bfee16	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	A-S Medication Solutions	ec433be5-d84d-425f-9edf-71263f885eec	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	Bryant Ranch Prepack	04cc10ad-7d5c-434e-9b29-85b14071492b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	83c1f93b-0fc6-4512-9c8f-9167b217d7f9	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	b29916fb-1781-4112-9c3e-45478754d638	2017-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071307 application number: ANDA071307

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	0bfdf83c-6ae3-09e9-e054-00144ff88e88	22
197589	diazepam 10 MG Oral Tablet	SCD	0bfdf83c-6ae3-09e9-e054-00144ff88e88	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0291-2	67296029102	2 TABLET in 1 BOTTLE (67296-0291-2)	2 tablet	2015-01-01	0000-00-00	No	No	Current