FDA.reportPublic FDA data

Diazepam

Product NDC
63629-1523
11-digit product format
636291523
Labeler code
63629
Product ID
63629-1523_fc6ec7d9-ec72-4ba7-929f-0460f00e71dc
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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1523-02020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-12020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-22020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-32020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-42020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-52020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-62020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-72020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-82020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-92020-10-13C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-02020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-12020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-22020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-32020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-42020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-52020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-62020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-72020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-82020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only
63629-1523-92020-01-31C16284748780-19d75b9d0-51d6-f424-e053-dadaa90a57ceDiazepam Tablets, USP, CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1523-0Diazepam120 in 1 BOTTLETABLET1201008
63629-1523-1Diazepam12 in 1 BOTTLETABLET121008
63629-1523-2Diazepam15 in 1 BOTTLETABLET151008
63629-1523-3Diazepam20 in 1 BOTTLETABLET201008
63629-1523-4Diazepam30 in 1 BOTTLETABLET301008
63629-1523-5Diazepam60 in 1 BOTTLETABLET601008
63629-1523-6Diazepam90 in 1 BOTTLETABLET901008
63629-1523-7Diazepam10 in 1 BOTTLETABLET101008
63629-1523-8Diazepam100 in 1 BOTTLETABLET1001008
63629-1523-9Diazepam1 in 1 BOTTLETABLET11008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1523-1EA - Each63629-1523c323d7f9-12c9-4f16-a130-d4e9eb6fdb8112013-02-13
63629-1523-2EA - Each63629-152301821717-89b0-4cd3-83a7-1617ee81441712013-02-13
63629-1523-3EA - Each63629-15236071e028-6a96-4df5-99c4-bfb1ba51bd1812013-02-13
63629-1523-4EA - Each63629-152359c190b6-bfb0-4466-aaff-3e407a47cfb312013-02-13
63629-1523-5EA - Each63629-1523c8622347-9e6b-4f04-879d-05163038ce0612013-02-13
63629-1523-6EA - Each63629-15237761dbc9-c23f-4f00-8d1b-7dfe3693b8de12013-02-13
63629-1523-7EA - Each63629-1523c3612137-0878-45e6-9649-4f6c992fa74e12013-02-13
63629-1523-8EA - Each63629-1523e09f75db-5de4-45e9-a9da-db00f7b6fd9412013-02-13
63629-1523-9EA - Each63629-1523d0aa2b83-fb14-448f-84fe-d9969c35317612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1523DIAZEPAM TABLET [BRYANT RANCH PREPACK]1008Current NDC, Legacy NDC, 10 package rows20240517_e8e4d5f5-3b4c-4c0f-a818-9da86389473c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSNe8e4d5f5-3b4c-4c0f-a818-9da86389473c1008
197591diazepam 5 MG Oral TabletSCDe8e4d5f5-3b4c-4c0f-a818-9da86389473c1008
197591diazePAM 5 MG Oral TabletPSN6abedac6-5133-47b2-a0e3-e239e0a2254b101
197591diazepam 5 MG Oral TabletSCD6abedac6-5133-47b2-a0e3-e239e0a2254b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1523-063629152300120 TABLET in 1 BOTTLE (63629-1523-0) 120 tablet2012-01-180000-00-00NoNoCurrent
63629-1523-16362915230112 TABLET in 1 BOTTLE (63629-1523-1) 12 tablet2005-10-040000-00-00NoNoCurrent
63629-1523-26362915230215 TABLET in 1 BOTTLE (63629-1523-2) 15 tablet2007-04-090000-00-00NoNoCurrent
63629-1523-36362915230320 TABLET in 1 BOTTLE (63629-1523-3) 20 tablet2005-11-160000-00-00NoNoCurrent
63629-1523-46362915230430 TABLET in 1 BOTTLE (63629-1523-4) 30 tablet2006-04-060000-00-00NoNoCurrent
63629-1523-56362915230560 TABLET in 1 BOTTLE (63629-1523-5) 60 tablet2006-02-020000-00-00NoNoCurrent
63629-1523-66362915230690 TABLET in 1 BOTTLE (63629-1523-6) 90 tablet2006-06-060000-00-00NoNoCurrent
63629-1523-76362915230710 TABLET in 1 BOTTLE (63629-1523-7) 10 tablet2007-10-230000-00-00NoNoCurrent
63629-1523-863629152308100 TABLET in 1 BOTTLE (63629-1523-8) 100 tablet1986-12-100000-00-00NoNoCurrent
63629-1523-9636291523091 TABLET in 1 BOTTLE (63629-1523-9) 1 tablet2008-07-230000-00-00NoNoCurrent