Diazepam

Product NDC: 63629-1523
Requested package NDC: 63629-1523-2
11-digit product format: 636291523
Labeler code: 63629
Product ID: 63629-1523_fc6ec7d9-ec72-4ba7-929f-0460f00e71dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA071321
Marketing category: ANDA
Marketing start: 1986-12-10
Substance: DIAZEPAM
Active strength: 5 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

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 · 1 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
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-1523	63629-1523-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
A071321-001	DIAZEPAM	DIAZEPAM	5MG	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
A071321-001	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	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071321-001	DIAZEPAM	5MG	TABLET / ORAL	AB	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071321-001	DIAZEPAM	5MG	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	A071321-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071321-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071321-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071321-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071321-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071321-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071321-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071321-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071321-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071321-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071321-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071321-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071321-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071321-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071321-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071321-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071321-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071321-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071321-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071321-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071321-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071321-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071321-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071321-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071321-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071321-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071321-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071321-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071321-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071321-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071321-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071321-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071321-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071321-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071321-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071321-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071321-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071321-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071321-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071321-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	5 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
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
e8e4d5f5-3b4c-4c0f-a818-9da86389473c	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-1523-0	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-1	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-2	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-3	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-4	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-5	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-6	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-7	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-8	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-9	2020-10-13	Diazepam Tablets, USP, CIV Rx only
63629-1523-0	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-1	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-2	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-3	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-4	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-5	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-6	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-7	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-8	2020-01-31	Diazepam Tablets, USP, CIV Rx only
63629-1523-9	2020-01-31	Diazepam Tablets, USP, CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-1523-0	Diazepam	120 in 1 BOTTLE	TABLET	120	1008
63629-1523-1	Diazepam	12 in 1 BOTTLE	TABLET	12	1008
63629-1523-2	Diazepam	15 in 1 BOTTLE	TABLET	15	1008
63629-1523-3	Diazepam	20 in 1 BOTTLE	TABLET	20	1008
63629-1523-4	Diazepam	30 in 1 BOTTLE	TABLET	30	1008
63629-1523-5	Diazepam	60 in 1 BOTTLE	TABLET	60	1008
63629-1523-6	Diazepam	90 in 1 BOTTLE	TABLET	90	1008
63629-1523-7	Diazepam	10 in 1 BOTTLE	TABLET	10	1008
63629-1523-8	Diazepam	100 in 1 BOTTLE	TABLET	100	1008
63629-1523-9	Diazepam	1 in 1 BOTTLE	TABLET	1	1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1523-1	EA - Each	63629-1523	c323d7f9-12c9-4f16-a130-d4e9eb6fdb81	1	2013-02-13
63629-1523-2	EA - Each	63629-1523	01821717-89b0-4cd3-83a7-1617ee814417	1	2013-02-13
63629-1523-3	EA - Each	63629-1523	6071e028-6a96-4df5-99c4-bfb1ba51bd18	1	2013-02-13
63629-1523-4	EA - Each	63629-1523	59c190b6-bfb0-4466-aaff-3e407a47cfb3	1	2013-02-13
63629-1523-5	EA - Each	63629-1523	c8622347-9e6b-4f04-879d-05163038ce06	1	2013-02-13
63629-1523-6	EA - Each	63629-1523	7761dbc9-c23f-4f00-8d1b-7dfe3693b8de	1	2013-02-13
63629-1523-7	EA - Each	63629-1523	c3612137-0878-45e6-9649-4f6c992fa74e	1	2013-02-13
63629-1523-8	EA - Each	63629-1523	e09f75db-5de4-45e9-a9da-db00f7b6fd94	1	2013-02-13
63629-1523-9	EA - Each	63629-1523	d0aa2b83-fb14-448f-84fe-d9969c353176	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1523	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	1008	Current NDC, Legacy NDC, 10 package rows	20240517_e8e4d5f5-3b4c-4c0f-a818-9da86389473c.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	20e08b97-bb89-4129-a228-8ad9cf35a1d3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Coupler LLC	5114ae6e-8cae-e96f-e063-6294a90a9e60	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
DIAZEPAM	DIAZEPAM	Direct_Rx	4b0c9c0a-4274-4d56-a7a4-bc497916469c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	2483426d-3782-432a-8b8d-86c06ef0de4a	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	A-S Medication Solutions	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	823093aa-d0cd-53c9-e053-2a91aa0a5235	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	8b3cc5c9-91bd-7467-e053-2a95a90a44b8	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Bryant Ranch Prepack	6abedac6-5133-47b2-a0e3-e239e0a2254b	2024-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Bryant Ranch Prepack	e8e4d5f5-3b4c-4c0f-a818-9da86389473c	2024-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321 ndc (package): 63629-1523-2 ndc (product): 63629-1523 ndc11 (package): 63629152302
Diazepam	DIAZEPAM	A-S Medication Solutions	af9a7906-4dca-4c1f-b16b-9b666a86b363	2024-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Clinical Solutions Wholesale, LLC	87b0fbb9-0c05-4ab0-8efe-7ffcae85b868	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Proficient Rx LP	e7542d46-2586-4225-b07d-2633116bfa0a	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	bdb8feda-01c6-45bd-bd66-97196ccce70c	2019-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071321 application number: ANDA071321

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
197591	diazePAM 5 MG Oral Tablet	PSN	e8e4d5f5-3b4c-4c0f-a818-9da86389473c	1008
197591	diazepam 5 MG Oral Tablet	SCD	e8e4d5f5-3b4c-4c0f-a818-9da86389473c	1008
197591	diazePAM 5 MG Oral Tablet	PSN	6abedac6-5133-47b2-a0e3-e239e0a2254b	101
197591	diazepam 5 MG Oral Tablet	SCD	6abedac6-5133-47b2-a0e3-e239e0a2254b	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1523-2	63629152302	15 TABLET in 1 BOTTLE (63629-1523-2)	15 tablet	2007-04-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Tablets, USP, CIV Rx only	Bryant Ranch Prepack	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL	101
Diazepam Tablets, USP, CIV Rx only	Bryant Ranch Prepack	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	1008