DIAZEPAM

Product NDC: 76420-314
Requested package NDC: 76420-314-20
11-digit product format: 764200314
Labeler code: 76420
Product ID: 76420-314_42708657-5977-a009-e063-6294a90a3919
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DIAZEPAM
Dosage form: TABLET
Route: ORAL
Labeler: ASCLEMED USA INC.
Application: ANDA217843
Marketing category: ANDA
Marketing start: 2023-12-14
Substance: DIAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217843-001	DIAZEPAM	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14
A217843-002	DIAZEPAM	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14
A217843-003	DIAZEPAM	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217843-001	AB
A217843-002	AB
A217843-003	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 2 · 57 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
2026-09-14 22:38:34	2026-08	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-002	DIAZEPAM	5MG	TABLET / ORAL	AB	2023-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-003	DIAZEPAM	10MG	TABLET / ORAL	AB	2023-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-001	DIAZEPAM	2MG	TABLET / ORAL	AB	2023-12-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 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	A217843-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217843-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217843-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217843-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217843-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217843-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217843-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217843-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217843-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217843-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217843-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217843-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217843-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217843-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217843-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217843-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217843-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217843-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217843-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217843-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217843-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: DIAZEPAM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	2 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197589	Internal RxNorm lookup
197590	Internal RxNorm lookup
197591	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
426f3da1-4105-ba0a-e063-6294a90a7a86	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	SPL version
76420-314-01	DIAZEPAM	100 in 1 BOTTLE	TABLET	100	1
76420-314-05	DIAZEPAM	500 in 1 BOTTLE	TABLET	500	1
76420-314-10	DIAZEPAM	10 in 1 BOTTLE	TABLET	10	1
76420-314-20	DIAZEPAM	20 in 1 BOTTLE	TABLET	20	1
76420-314-30	DIAZEPAM	30 in 1 BOTTLE	TABLET	30	1
76420-314-60	DIAZEPAM	60 in 1 BOTTLE	TABLET	60	1
76420-314-90	DIAZEPAM	90 in 1 BOTTLE	TABLET	90	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIAZEPAM	DIAZEPAM	ASCLEMED USA INC.	426f3da1-4105-ba0a-e063-6294a90a7a86	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843 ndc (package): 76420-314-20 ndc (product): 76420-314 ndc11 (package): 76420031420
DIAZEPAM	DIAZEPAM	Advanced Rx of Tennessee, LLC	32c3af91-a57a-1278-e063-6294a90ae5ec	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	Proficient Rx LP	9322b0bc-e9fa-4c89-808b-110decf6db58	2025-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	NuCare Pharmaceuticals, Inc.	21785bb2-cc96-7973-e063-6294a90ab1b8	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	NuCare Pharmaceuticals, Inc	22688087-27ad-620c-e063-6394a90a134c	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843
DIAZEPAM	DIAZEPAM	Aurobindo Pharma Limited	2f799120-0d08-47cd-8183-a98f0267c845	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217843 application number: ANDA217843

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	426f3da1-4105-ba0a-e063-6294a90a7a86	1
197590	diazePAM 2 MG Oral Tablet	PSN	426f3da1-4105-ba0a-e063-6294a90a7a86	1
197591	diazePAM 5 MG Oral Tablet	PSN	426f3da1-4105-ba0a-e063-6294a90a7a86	1
197589	diazepam 10 MG Oral Tablet	SCD	426f3da1-4105-ba0a-e063-6294a90a7a86	1
197590	diazepam 2 MG Oral Tablet	SCD	426f3da1-4105-ba0a-e063-6294a90a7a86	1
197591	diazepam 5 MG Oral Tablet	SCD	426f3da1-4105-ba0a-e063-6294a90a7a86	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-314-20	76420031420	20 TABLET in 1 BOTTLE (76420-314-20)	20 tablet	2025-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Tablets, USP CIV Rx only	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	1