Danazol

Product NDC
68151-2298
11-digit product format
681512298
Labeler code
68151
Product ID
68151-2298_79371e5b-3968-4c5d-9ef7-c78e92f64080
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Danazol
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA077246
Marketing category
ANDA
Marketing start
2005-09-28
Marketing end
0000-00-00
Substance
DANAZOL
Active strength
200 mg/1
Pharmacologic classes
Androgen Receptor Agonists [MoA],Androstanes [CS],Androgen [EPC]
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
75693c89-6d89-3c6a-9c3f-cbfd21877b44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2298-02020-01-31C16284748780-19d75b9d0-1bdc-f424-e053-dadaa90a57ceDANAZOL CAPSULES, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2298-0Danazol1 in 1 PACKAGECAPSULE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DANAZOLACTIVE INGREDIENTN29QWW3BUODANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
DANAZOLACTIVE MOIETYN29QWW3BUODANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ODANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2298DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140708_35a21f89-cf5f-4e8b-8400-3ef7023bc49c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197555danazol 200 MG Oral CapsulePSN35a21f89-cf5f-4e8b-8400-3ef7023bc49c2
197555danazol 200 MG Oral CapsuleSCD35a21f89-cf5f-4e8b-8400-3ef7023bc49c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2298-0681512298001 in 1 PACKAGEHistorical