Diazepam

Product NDC
68071-4770
11-digit product format
680714770
Labeler code
68071
Product ID
68071-4770_1adbdaf5-93ea-eeda-e063-6394a90a1cb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,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
Rxcui197591

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4770-1Diazepam10 in 1 BOTTLETABLET106
68071-4770-3Diazepam30 in 1 BOTTLETABLET306
68071-4770-5Diazepam15 in 1 BOTTLETABLET156
68071-4770-9Diazepam90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4770DIAZEPAM TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 4 package rows20240616_823093aa-d0cd-53c9-e053-2a91aa0a5235.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN823093aa-d0cd-53c9-e053-2a91aa0a52356
197591diazepam 5 MG Oral TabletSCD823093aa-d0cd-53c9-e053-2a91aa0a52356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4770-16807147700110 TABLET in 1 BOTTLE (68071-4770-1) 10 tablet2019-02-180000-00-00NoNoCurrent
68071-4770-36807147700330 TABLET in 1 BOTTLE (68071-4770-3) 30 tablet2019-02-180000-00-00NoNoCurrent
68071-4770-56807147700515 TABLET in 1 BOTTLE (68071-4770-5) 15 tablet2019-02-180000-00-00NoNoCurrent
68071-4770-96807147700990 TABLET in 1 BOTTLE (68071-4770-9) 90 tablet2019-02-180000-00-00NoNoCurrent