FDA.reportPublic FDA data

Diazepam

Product NDC
76420-783
11-digit product format
764200783
Labeler code
76420
Product ID
76420-783_2cb3e981-e5b2-9d49-e063-6394a90abfbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA071307
Marketing category
ANDA
Marketing start
1986-12-10
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589, 197590, 197591

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69057c52-36b0-21c0-02d6-d697be15c03cProduct name420260305
da74e203-d183-4c62-8511-c3ef56b5964eProduct name120250213
2792dd44-ff30-4712-8b05-1850c2b4d307Product name320250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876Product name220250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42bProduct name220240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-783-01Diazepam100 in 1 BOTTLETABLET1003
76420-783-02Diazepam2 in 1 BOTTLETABLET23
76420-783-03Diazepam3 in 1 BOTTLETABLET33
76420-783-05Diazepam5 in 1 BOTTLETABLET53
76420-783-10Diazepam10 in 1 BOTTLETABLET103
76420-783-20Diazepam20 in 1 BOTTLETABLET203
76420-783-30Diazepam30 in 1 BOTTLETABLET303
76420-783-55Diazepam500 in 1 BOTTLETABLET5003
76420-783-60Diazepam60 in 1 BOTTLETABLET603
76420-783-90Diazepam90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-783-01EA - Each76420-783cbef257c-8178-4df5-8f8b-41fbcb5f002512026-05-22
76420-783-02EA - Each76420-7831d131c70-aa17-4b0a-8a09-10fd7eebf48a12026-05-22
76420-783-03EA - Each76420-7839abcb07a-4272-4305-a746-87d9d4f031d012026-05-22
76420-783-05EA - Each76420-78374f1ddde-b43c-4224-af57-5c4d248319b212026-05-22
76420-783-10EA - Each76420-7830622b41c-39fa-4724-a257-4eee1801a02912026-05-22
76420-783-20EA - Each76420-783640d5894-572d-4459-a029-73c04596c96312026-05-22
76420-783-30EA - Each76420-783dc092793-6693-499b-aab0-28e69ca8f05712026-05-22
76420-783-55EA - Each76420-7834fbf2272-383c-4e42-b250-db3cfab4c8d912026-05-22
76420-783-60EA - Each76420-78305975114-3f4f-469a-855c-a272d34e32f412026-05-22
76420-783-90EA - Each76420-783cbf9dbe4-0f7a-469c-99a1-ddcea925e98712026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-783DIAZEPAM TABLET [ASCLEMED USA, INC.]3Current NDC, 10 package rows20250129_32e7bfa1-6060-4041-a0e5-249cacb84ebc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN32e7bfa1-6060-4041-a0e5-249cacb84ebc3
197590diazePAM 2 MG Oral TabletPSN32e7bfa1-6060-4041-a0e5-249cacb84ebc3
197591diazePAM 5 MG Oral TabletPSN32e7bfa1-6060-4041-a0e5-249cacb84ebc3
197589diazepam 10 MG Oral TabletSCD32e7bfa1-6060-4041-a0e5-249cacb84ebc3
197590diazepam 2 MG Oral TabletSCD32e7bfa1-6060-4041-a0e5-249cacb84ebc3
197591diazepam 5 MG Oral TabletSCD32e7bfa1-6060-4041-a0e5-249cacb84ebc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-783-0176420078301100 TABLET in 1 BOTTLE (76420-783-01) 100 tablet2024-03-08NoNoHistorical
76420-783-02764200783022 TABLET in 1 BOTTLE (76420-783-02) 2 tablet2025-01-27NoNoHistorical
76420-783-03764200783033 TABLET in 1 BOTTLE (76420-783-03) 3 tablet2025-01-27NoNoHistorical
76420-783-05764200783055 TABLET in 1 BOTTLE (76420-783-05) 5 tablet2025-01-27NoNoHistorical
76420-783-107642007831010 TABLET in 1 BOTTLE (76420-783-10) 10 tablet2025-01-27NoNoHistorical
76420-783-207642007832020 TABLET in 1 BOTTLE (76420-783-20) 20 tablet2025-01-27NoNoHistorical
76420-783-307642007833030 TABLET in 1 BOTTLE (76420-783-30) 30 tablet2024-03-08NoNoHistorical
76420-783-5576420078355500 TABLET in 1 BOTTLE (76420-783-55) 500 tablet2025-01-27NoNoHistorical
76420-783-607642007836060 TABLET in 1 BOTTLE (76420-783-60) 60 tablet2024-03-08NoNoHistorical
76420-783-907642007839090 TABLET in 1 BOTTLE (76420-783-90) 90 tablet2024-03-08NoNoHistorical