FDA.reportPublic FDA data

Danazol

Product NDC
0555-0635
11-digit product format
005550635
Labeler code
0555
Product ID
0555-0635_012ba27f-5410-4461-bc8a-72004ac311a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Danazol
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074582
Marketing category
ANDA
Marketing start
1996-08-09
Substance
DANAZOL
Active strength
200 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
DANAZOL200 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
0555-0635-02Danazol100 in 1 BOTTLECAPSULE10015
0555-0635-09Danazol60 in 1 BOTTLECAPSULE6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0635-02EA - Each0555-0635861f8dbd-dfc9-439f-88fa-b47bc24f8cec12012-07-24
0555-0635-09EA - Each0555-0635a62bb92f-2feb-4a7f-9f78-de89aa8743ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DANAZOLACTIVE INGREDIENTN29QWW3BUODANAZOL CAPSULE [BARR LABORATORIES INC.]6
DANAZOLACTIVE MOIETYN29QWW3BUODANAZOL CAPSULE [BARR LABORATORIES INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DANAZOL CAPSULE [BARR LABORATORIES INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDANAZOL CAPSULE [BARR LABORATORIES INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDANAZOL CAPSULE [BARR LABORATORIES INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDANAZOL CAPSULE [BARR LABORATORIES INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDANAZOL CAPSULE [BARR LABORATORIES INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADANAZOL CAPSULE [BARR LABORATORIES INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DANAZOL CAPSULE [BARR LABORATORIES INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DANAZOL CAPSULE [BARR LABORATORIES INC.]6
GELATININACTIVE INGREDIENT2G86QN327LDANAZOL CAPSULE [BARR LABORATORIES INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDANAZOL CAPSULE [BARR LABORATORIES INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DANAZOL CAPSULE [BARR LABORATORIES INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DANAZOL CAPSULE [BARR LABORATORIES INC.]6
SHELLACINACTIVE INGREDIENT46N107B71ODANAZOL CAPSULE [BARR LABORATORIES INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DANAZOL CAPSULE [BARR LABORATORIES INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDANAZOL CAPSULE [BARR LABORATORIES INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDANAZOL CAPSULE [BARR LABORATORIES INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0635DANAZOL CAPSULE [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20250322_e19acee5-ff33-45a5-bbbf-801756bc59b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197554danazol 100 MG Oral CapsulePSNe19acee5-ff33-45a5-bbbf-801756bc59b415
197555danazol 200 MG Oral CapsulePSNe19acee5-ff33-45a5-bbbf-801756bc59b415
197556danazol 50 MG Oral CapsulePSNe19acee5-ff33-45a5-bbbf-801756bc59b415
197554danazol 100 MG Oral CapsuleSCDe19acee5-ff33-45a5-bbbf-801756bc59b415
197555danazol 200 MG Oral CapsuleSCDe19acee5-ff33-45a5-bbbf-801756bc59b415
197556danazol 50 MG Oral CapsuleSCDe19acee5-ff33-45a5-bbbf-801756bc59b415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0635-0200555063502100 CAPSULE in 1 BOTTLE (0555-0635-02) 100 capsule1996-08-090000-00-00NoNoCurrent
0555-0635-090055506350960 CAPSULE in 1 BOTTLE (0555-0635-09) 60 capsule1996-08-090000-00-00NoNoCurrent