FDA.reportPublic FDA data

Diazepam

Product NDC
76420-533
11-digit product format
764200533
Labeler code
76420
Product ID
76420-533_2cb3e981-e5b2-9d49-e063-6394a90abfbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 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
76420-533-00Diazepam1000 in 1 BOTTLETABLET10003
76420-533-01Diazepam100 in 1 BOTTLETABLET1003
76420-533-02Diazepam2 in 1 BOTTLETABLET23
76420-533-03Diazepam3 in 1 BOTTLETABLET33
76420-533-05Diazepam5 in 1 BOTTLETABLET53
76420-533-10Diazepam10 in 1 BOTTLETABLET103
76420-533-20Diazepam20 in 1 BOTTLETABLET203
76420-533-30Diazepam30 in 1 BOTTLETABLET303
76420-533-55Diazepam500 in 1 BOTTLETABLET5003
76420-533-60Diazepam60 in 1 BOTTLETABLET603
76420-533-90Diazepam90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-533-00EA - Each76420-5338116dec8-522d-4df8-a12d-426ec06bbfbb12026-05-22
76420-533-01EA - Each76420-533b3660252-37fd-4604-9a85-acc8689e302a12024-01-04
76420-533-02EA - Each76420-5339e66583a-4bfa-4bc2-b198-ab21a5b9206712026-05-22
76420-533-03EA - Each76420-533a7b20bb8-08cf-4ab7-b3cf-dc45997e8c8712026-05-22
76420-533-05EA - Each76420-533273a2b85-c21e-4427-97c2-fe263018672712026-05-22
76420-533-10EA - Each76420-53394918a34-b166-4242-9f11-80e5fb6b3d5c12026-05-22
76420-533-20EA - Each76420-533fb81dc4d-f187-49f9-b55a-2827b26313f312026-05-22
76420-533-30EA - Each76420-5336fb6d263-d43b-4e21-a5a0-9ba259e77b0312026-05-22
76420-533-55EA - Each76420-5332a0b0a08-e3ff-4144-8274-146a7ac2797412026-05-22
76420-533-60EA - Each76420-533c66d2ab0-2650-4659-9ce7-66a15d346c6912026-05-22
76420-533-90EA - Each76420-533aa832d25-b45a-46ce-ade9-6f64f1cfacd612026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-533DIAZEPAM TABLET [ASCLEMED USA, INC.]3Current NDC, 11 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
76420-533-00764200533001000 TABLET in 1 BOTTLE (76420-533-00) 1000 tablet2025-01-27NoNoHistorical
76420-533-0176420053301100 TABLET in 1 BOTTLE (76420-533-01) 100 tablet2023-01-14NoNoHistorical
76420-533-02764200533022 TABLET in 1 BOTTLE (76420-533-02) 2 tablet2025-01-27NoNoHistorical
76420-533-03764200533033 TABLET in 1 BOTTLE (76420-533-03) 3 tablet2025-01-27NoNoHistorical
76420-533-05764200533055 TABLET in 1 BOTTLE (76420-533-05) 5 tablet2025-01-27NoNoHistorical
76420-533-107642005331010 TABLET in 1 BOTTLE (76420-533-10) 10 tablet2025-01-27NoNoHistorical
76420-533-207642005332020 TABLET in 1 BOTTLE (76420-533-20) 20 tablet2025-01-27NoNoHistorical
76420-533-307642005333030 TABLET in 1 BOTTLE (76420-533-30) 30 tablet2024-03-08NoNoHistorical
76420-533-5576420053355500 TABLET in 1 BOTTLE (76420-533-55) 500 tablet2025-01-27NoNoHistorical
76420-533-607642005336060 TABLET in 1 BOTTLE (76420-533-60) 60 tablet2024-03-08NoNoHistorical
76420-533-907642005339090 TABLET in 1 BOTTLE (76420-533-90) 90 tablet2024-03-08NoNoHistorical