FDA.reportPublic FDA data

Danazol

Product NDC
0527-1368
11-digit product format
005271368
Labeler code
0527
Product ID
0527-1368_399a377e-237d-4939-ad70-805ebd30a1c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Danazol
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA078214
Marketing category
ANDA
Marketing start
2007-04-19
Substance
DANAZOL
Active strength
100 mg/1
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Danazol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DANAZOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN29QWW3BUO
Rxcui197554, 197555, 197556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75693c89-6d89-3c6a-9c3f-cbfd21877b44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1368-01Danazol100 in 1 BOTTLECAPSULE10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1368-01EA - Each0527-13682bc8582c-e359-4447-b8cf-6d89fe4affcf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DANAZOLACTIVE INGREDIENTN29QWW3BUODANAZOL CAPSULE [LANNETT COMPANY, INC.]18
DANAZOLACTIVE MOIETYN29QWW3BUODANAZOL CAPSULE [LANNETT COMPANY, INC.]18
ALCOHOLINACTIVE INGREDIENT3K9958V90MDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DANAZOL CAPSULE [LANNETT COMPANY, INC.]18
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DANAZOL CAPSULE [LANNETT COMPANY, INC.]18
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADANAZOL CAPSULE [LANNETT COMPANY, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DANAZOL CAPSULE [LANNETT COMPANY, INC.]18
GELATININACTIVE INGREDIENT2G86QN327LDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DANAZOL CAPSULE [LANNETT COMPANY, INC.]18
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15DANAZOL CAPSULE [LANNETT COMPANY, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DANAZOL CAPSULE [LANNETT COMPANY, INC.]18
SHELLACINACTIVE INGREDIENT46N107B71ODANAZOL CAPSULE [LANNETT COMPANY, INC.]18
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UDANAZOL CAPSULE [LANNETT COMPANY, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDANAZOL CAPSULE [LANNETT COMPANY, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1368DANAZOL CAPSULE [LANNETT COMPANY, INC.]28Current NDC, Legacy NDC, 1 package rows20220729_f2c9b713-aafc-49ca-866e-334d9b5c2e2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197554danazol 100 MG Oral CapsulePSNf2c9b713-aafc-49ca-866e-334d9b5c2e2d28
197555danazol 200 MG Oral CapsulePSNf2c9b713-aafc-49ca-866e-334d9b5c2e2d28
197556danazol 50 MG Oral CapsulePSNf2c9b713-aafc-49ca-866e-334d9b5c2e2d28
197554danazol 100 MG Oral CapsuleSCDf2c9b713-aafc-49ca-866e-334d9b5c2e2d28
197555danazol 200 MG Oral CapsuleSCDf2c9b713-aafc-49ca-866e-334d9b5c2e2d28
197556danazol 50 MG Oral CapsuleSCDf2c9b713-aafc-49ca-866e-334d9b5c2e2d28
197554danazol 100 MG Oral CapsulePSN9e103cf9-f075-48ba-8913-2e44f94427811
197555danazol 200 MG Oral CapsulePSN9e103cf9-f075-48ba-8913-2e44f94427811
197554danazol 100 MG Oral CapsuleSCD9e103cf9-f075-48ba-8913-2e44f94427811
197555danazol 200 MG Oral CapsuleSCD9e103cf9-f075-48ba-8913-2e44f94427811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1368-0100527136801100 CAPSULE in 1 BOTTLE (0527-1368-01) 100 capsule2007-04-190000-00-00NoNoCurrent