Danazol

Product NDC: 0527-1369
11-digit product format: 005271369
Labeler code: 0527
Product ID: 0527-1369_399a377e-237d-4939-ad70-805ebd30a1c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Danazol
Dosage form: CAPSULE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA077246
Marketing category: ANDA
Marketing start: 2005-09-28
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
Ingredient	Strength
DANAZOL	200 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	N29QWW3BUO
Rxcui	197554, 197555, 197556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75693c89-6d89-3c6a-9c3f-cbfd21877b44	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0527-1369-01	Danazol	100 in 1 BOTTLE	CAPSULE	100		28
0527-1369-06	Danazol	60 in 1 BOTTLE	CAPSULE	60		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1369-01	EA - Each	0527-1369	88cee847-417a-47f3-9ae2-ac28264070e0	1	2012-07-24
0527-1369-06	EA - Each	0527-1369	87ffac71-b219-4485-95d6-8e61d42ddbeb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DANAZOL	ACTIVE INGREDIENT	N29QWW3BUO	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
DANAZOL	ACTIVE MOIETY	N29QWW3BUO	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	18
DANAZOL	ACTIVE INGREDIENT	N29QWW3BUO	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
DANAZOL	ACTIVE MOIETY	N29QWW3BUO	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1369	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	28	Current NDC, Legacy NDC, 2 package rows	20220729_f2c9b713-aafc-49ca-866e-334d9b5c2e2d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N29QWW3BUO	DANAZOL	17230-88-5	DANAZOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197554	danazol 100 MG Oral Capsule	PSN	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	28
197555	danazol 200 MG Oral Capsule	PSN	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	28
197556	danazol 50 MG Oral Capsule	PSN	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	28
197554	danazol 100 MG Oral Capsule	SCD	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	28
197555	danazol 200 MG Oral Capsule	SCD	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	28
197556	danazol 50 MG Oral Capsule	SCD	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	28
197555	danazol 200 MG Oral Capsule	PSN	35a21f89-cf5f-4e8b-8400-3ef7023bc49c	2
197555	danazol 200 MG Oral Capsule	SCD	35a21f89-cf5f-4e8b-8400-3ef7023bc49c	2
197554	danazol 100 MG Oral Capsule	PSN	9e103cf9-f075-48ba-8913-2e44f9442781	1
197555	danazol 200 MG Oral Capsule	PSN	9e103cf9-f075-48ba-8913-2e44f9442781	1
197554	danazol 100 MG Oral Capsule	SCD	9e103cf9-f075-48ba-8913-2e44f9442781	1
197555	danazol 200 MG Oral Capsule	SCD	9e103cf9-f075-48ba-8913-2e44f9442781	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1369-01	00527136901	100 CAPSULE in 1 BOTTLE (0527-1369-01)	100 capsule	2005-09-28	0000-00-00	No	No	Current
0527-1369-06	00527136906	60 CAPSULE in 1 BOTTLE (0527-1369-06)	60 capsule	2005-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Danazol Capsules, USP Rx only	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	1
Danazol Capsules, USP Rx only	Lannett Company, Inc.	2020-04-30	HUMAN PRESCRIPTION DRUG LABEL	28
DANAZOL CAPSULES, USP Rx only	Carilion Materials Management	2012-01-26	HUMAN PRESCRIPTION DRUG LABEL	2

Danazol

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#