Diazepam

Product NDC
71335-1584
11-digit product format
713351584
Labeler code
71335
Product ID
71335-1584_dc33c03b-c55f-4b37-9b2b-85c949d2a1c3
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

openFDA Listing Details

Product ID
71335-1584_dc33c03b-c55f-4b37-9b2b-85c949d2a1c3
SPL ID
dc33c03b-c55f-4b37-9b2b-85c949d2a1c3
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Diazepam
Generic name
Diazepam
Dosage form
TABLET
Route
ORAL
Marketing start
1986-12-10
Marketing category
ANDA
Application number
ANDA071321
Pharmacologic classes
Benzodiazepine [EPC]; Benzodiazepines [CS]
DEA schedule
CIV
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
DIAZEPAM5 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiQ3JTX2Q7TU
Rxcui197591
Spl Set Id6abedac6-5133-47b2-a0e3-e239e0a2254b
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-1584-0120 TABLET in 1 BOTTLE (71335-1584-0)2022-02-10No
71335-1584-112 TABLET in 1 BOTTLE (71335-1584-1)2022-02-10No
71335-1584-215 TABLET in 1 BOTTLE (71335-1584-2)2022-02-10No
71335-1584-320 TABLET in 1 BOTTLE (71335-1584-3)2022-02-10No
71335-1584-430 TABLET in 1 BOTTLE (71335-1584-4)2022-02-10No
71335-1584-560 TABLET in 1 BOTTLE (71335-1584-5)2022-02-10No
71335-1584-690 TABLET in 1 BOTTLE (71335-1584-6)2022-02-10No
71335-1584-710 TABLET in 1 BOTTLE (71335-1584-7)2022-02-10No
71335-1584-82 TABLET in 1 BOTTLE (71335-1584-8)2022-02-10No
71335-1584-91 TABLET in 1 BOTTLE (71335-1584-9)2022-02-10No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
Q3JTX2Q7TUDIAZEPAM439-14-5DIAZEPAM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1584-071335158400120 TABLET in 1 BOTTLE (71335-1584-0) 120 tablet2022-02-10NoNoHistorical
71335-1584-17133515840112 TABLET in 1 BOTTLE (71335-1584-1) 12 tablet2022-02-10NoNoHistorical
71335-1584-27133515840215 TABLET in 1 BOTTLE (71335-1584-2) 15 tablet2022-02-10NoNoHistorical
71335-1584-37133515840320 TABLET in 1 BOTTLE (71335-1584-3) 20 tablet2022-02-10NoNoHistorical
71335-1584-47133515840430 TABLET in 1 BOTTLE (71335-1584-4) 30 tablet2022-02-10NoNoHistorical
71335-1584-57133515840560 TABLET in 1 BOTTLE (71335-1584-5) 60 tablet2022-02-10NoNoHistorical
71335-1584-67133515840690 TABLET in 1 BOTTLE (71335-1584-6) 90 tablet2022-02-10NoNoHistorical
71335-1584-77133515840710 TABLET in 1 BOTTLE (71335-1584-7) 10 tablet2022-02-10NoNoHistorical
71335-1584-8713351584082 TABLET in 1 BOTTLE (71335-1584-8) 2 tablet2022-02-10NoNoHistorical
71335-1584-9713351584091 TABLET in 1 BOTTLE (71335-1584-9) 1 tablet2022-02-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diazepam Tablets, USP, CIV Rx onlyBryant Ranch Prepack2024-05-20HUMAN PRESCRIPTION DRUG LABEL101