Diazepam

Product NDC: 67046-0944
11-digit product format: 670460944
Labeler code: 67046
Product ID: 67046-0944_51117502-db13-4816-e063-6394a90ac59e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA071322
Marketing category: ANDA
Marketing start: 2026-05-05
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071322-001	DIAZEPAM	DIAZEPAM	10MG	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
A071322-001	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	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071322-001	DIAZEPAM	10MG	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	A071322-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071322-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071322-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071322-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071322-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071322-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071322-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071322-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071322-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071322-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071322-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071322-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071322-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071322-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071322-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071322-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071322-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071322-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071322-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071322-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071322-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071322-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071322-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071322-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071322-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071322-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071322-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071322-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071322-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071322-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071322-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071322-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071322-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071322-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071322-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071322-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071322-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071322-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071322-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071322-001	AB	1	`cb3db0bc1861…`

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
5111654f-a026-71b2-e063-6294a90ab49b	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
67046-0944-3	Diazepam	30 in 1 BLISTER PACK	TABLET	30		1

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	5ebef149-1858-4199-aaed-7b9341fae63d	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Coupler LLC	5111654f-a026-71b2-e063-6294a90ab49b	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322 ndc (product): 67046-0944
Diazepam	DIAZEPAM	REMEDYREPACK INC.	d7a4b3c7-7021-4764-8c21-49e4bc6f6058	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
DIAZEPAM	DIAZEPAM	Direct_Rx	4b0c9c0a-4274-4d56-a7a4-bc497916469c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	84cecab3-d0e6-436b-996b-0b598e972308	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	A-S Medication Solutions	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	b7002d26-3856-4c2f-e053-2995a90aea60	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	859461ea-5861-8185-e053-2991aa0a954a	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Bryant Ranch Prepack	078bbb41-7e3a-48db-87f0-ec6a6ec0194e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	9cf031ae-d59b-430d-9b15-415ae2e49c98	2022-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Proficient Rx LP	f8d26f65-a015-4bfc-b1fa-8595d72af48c	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322

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	5111654f-a026-71b2-e063-6294a90ab49b	1
197589	diazepam 10 MG Oral Tablet	SCD	5111654f-a026-71b2-e063-6294a90ab49b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-0944-3	67046094403	30 TABLET in 1 BLISTER PACK (67046-0944-3)	30 tablet	2026-05-05	No	No	Current