DIAZEPAM

Product NDC
12634-529
11-digit product format
126340529
Labeler code
12634
Product ID
12634-529_7f85d8a7-0144-44d4-9a61-fb24a144d5c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc.
Application
ANDA071321
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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
12634-529-55DIAZEPAM15 in 1 BLISTER PACKTABLET153
12634-529-80DIAZEPAM20 in 1 BOTTLETABLET203
12634-529-91DIAZEPAM1 in 1 BLISTER PACKTABLET13
12634-529-96DIAZEPAM6 in 1 BOTTLETABLET63

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [APOTHECA, INC.]3
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [APOTHECA, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [APOTHECA, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [APOTHECA, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIAZEPAM TABLET [APOTHECA, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [APOTHECA, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [APOTHECA, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [APOTHECA, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [APOTHECA, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [APOTHECA, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [APOTHECA, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [APOTHECA, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [APOTHECA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-529DIAZEPAM TABLET [APOTHECA, INC.]3Legacy NDC, 4 package rows20100315_792c3767-f660-4d13-89ed-c69e925f2232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN792c3767-f660-4d13-89ed-c69e925f22323
197591diazePAM 5 MG Oral TabletPSN792c3767-f660-4d13-89ed-c69e925f22323
197589diazepam 10 MG Oral TabletSCD792c3767-f660-4d13-89ed-c69e925f22323
197591diazepam 5 MG Oral TabletSCD792c3767-f660-4d13-89ed-c69e925f22323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-529-551263405295515 in 1 BLISTER PACKHistorical
12634-529-801263405298020 in 1 BOTTLEHistorical
12634-529-91126340529911 in 1 BLISTER PACKHistorical
12634-529-96126340529966 in 1 BOTTLEHistorical