Valium

Product NDC: 80725-004
Requested package NDC: 80725-004-01
11-digit product format: 807250004
Labeler code: 80725
Product ID: 80725-004_ecf958a2-2749-5198-e053-2995a90a4def
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Waylis Therapuetics LLC
Application: NDA013263
Marketing category: NDA
Marketing start: 2022-04-04
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 2 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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80725-004	80725-004-01	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80725-004	80725-004-01	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS
N013263-002	VALIUM	DIAZEPAM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982
N013263-004	VALIUM	DIAZEPAM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982
N013263-006	VALIUM	DIAZEPAM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N013263-002	AB
N013263-004	AB
N013263-006	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-004	VALIUM	5MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-006	VALIUM	10MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013263-002	VALIUM	2MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N013263-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013263-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013263-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013263-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013263-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013263-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013263-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013263-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013263-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013263-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013263-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013263-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013263-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013263-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013263-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013263-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013263-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013263-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013263-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013263-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013263-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013263-002	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104699	Internal RxNorm lookup
104700	Internal RxNorm lookup
104701	Internal RxNorm lookup
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
260e2041-2bb3-482f-850e-b5d47a7bdbe6	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
80725-004-01	Valium	100 in 1 BOTTLE	TABLET	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80725-004-01	EA - Each	80725-004	9320cac0-165b-4189-88d1-fc58ce1c8850	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80725-004	VALIUM (DIAZEPAM) TABLET [WAYLIS THERAPUETICS LLC]	9	Legacy NDC, 1 package rows	20241116_260e2041-2bb3-482f-850e-b5d47a7bdbe6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valium	DIAZEPAM	Waylis Therapuetics LLC	260e2041-2bb3-482f-850e-b5d47a7bdbe6	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 013263 application number: NDA013263 ndc (package): 80725-004-01 ndc (product): 80725-004 ndc11 (package): 80725000401
Valium	DIAZEPAM	Roche Laboratories Inc.	554baee5-b171-4452-a50a-41a0946f956c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 013263 application number: NDA013263

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	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
197590	diazePAM 2 MG Oral Tablet	PSN	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
197591	diazePAM 5 MG Oral Tablet	PSN	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104701	Valium 10 MG Oral Tablet	PSN	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104699	Valium 2 MG Oral Tablet	PSN	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104700	Valium 5 MG Oral Tablet	PSN	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104701	diazepam 10 MG Oral Tablet [Valium]	SBD	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104699	diazepam 2 MG Oral Tablet [Valium]	SBD	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104700	diazepam 5 MG Oral Tablet [Valium]	SBD	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
197589	diazepam 10 MG Oral Tablet	SCD	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
197590	diazepam 2 MG Oral Tablet	SCD	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
197591	diazepam 5 MG Oral Tablet	SCD	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104701	Valium 10 MG Oral Tablet	SY	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104699	Valium 2 MG Oral Tablet	SY	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9
104700	Valium 5 MG Oral Tablet	SY	260e2041-2bb3-482f-850e-b5d47a7bdbe6	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80725-004-01	80725000401	100 TABLET in 1 BOTTLE (80725-004-01)	100 tablet	2022-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Waylis Therapeutics LLC CIV VALIUM ® brand of diazepam TABLETS	Waylis Therapuetics LLC \| Patheon, Inc.	2026-08-11	HUMAN PRESCRIPTION DRUG LABEL	11