Danazol

Product NDC: 0527-1368
Requested package NDC: 0527-1368-01
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

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DANAZOL	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N29QWW3BUO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197554	Internal RxNorm lookup
197555	Internal RxNorm lookup
197556	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f2c9b713-aafc-49ca-866e-334d9b5c2e2d	Available on FDA.report

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
0527-1368-01	Danazol	100 in 1 BOTTLE	CAPSULE	100		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1368-01	EA - Each	0527-1368	2bc8582c-e359-4447-b8cf-6d89fe4affcf	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1368	DANAZOL CAPSULE [LANNETT COMPANY, INC.]	28	Current NDC, Legacy NDC, 1 package rows	20220729_f2c9b713-aafc-49ca-866e-334d9b5c2e2d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Danazol	DANAZOL	Proficient Rx LP	9e103cf9-f075-48ba-8913-2e44f9442781	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078214 application number: ANDA078214
Danazol	DANAZOL	Lannett Company, Inc.	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	2020-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078214 application number: ANDA078214 ndc (package): 0527-1368-01 ndc (product): 0527-1368 ndc11 (package): 00527136801

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
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
0527-1368-01	00527136801	100 CAPSULE in 1 BOTTLE (0527-1368-01)	100 capsule	2007-04-19	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