Danazol
DANAZOL CAPSULES, USP Rx only
Approved
Approval ID
35a21f89-cf5f-4e8b-8400-3ef7023bc49c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2012
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Danazol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-2298
Application NumberANDA077246
Product Classification
M
Marketing Category
C73584
G
Generic Name
Danazol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2012
FDA Product Classification
INGREDIENTS (21)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
DANAZOLActive
Quantity: 200 mg in 1 1
Code: N29QWW3BUO
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT