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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074582-001	DANAZOL	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09
A074582-002	DANAZOL	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29
A074582-003	DANAZOL	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074582-001	AB
A074582-002	AB
A074582-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074582-002	DANAZOL	100MG	CAPSULE / ORAL	AB		1998-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074582-003	DANAZOL	50MG	CAPSULE / ORAL	AB		1998-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074582-001	DANAZOL	200MG	CAPSULE / ORAL	AB	RS	1996-08-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074582-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074582-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074582-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074582-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074582-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074582-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074582-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074582-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074582-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074582-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074582-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074582-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074582-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074582-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074582-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074582-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074582-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074582-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074582-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074582-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074582-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074582-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074582-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074582-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074582-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074582-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074582-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074582-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074582-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074582-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074582-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074582-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074582-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074582-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074582-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074582-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074582-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074582-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074582-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074582-001	AB	1	`1e350fbaab3a…`

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 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
e19acee5-ff33-45a5-bbbf-801756bc59b4	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
0555-0635-02	Danazol	100 in 1 BOTTLE	CAPSULE	100		15
0555-0635-09	Danazol	60 in 1 BOTTLE	CAPSULE	60		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0635-02	EA - Each	0555-0635	861f8dbd-dfc9-439f-88fa-b47bc24f8cec	1	2012-07-24
0555-0635-09	EA - Each	0555-0635	a62bb92f-2feb-4a7f-9f78-de89aa8743ee	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DANAZOL	ACTIVE INGREDIENT	N29QWW3BUO	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
DANAZOL	ACTIVE MOIETY	N29QWW3BUO	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DANAZOL CAPSULE [BARR LABORATORIES INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0635	DANAZOL CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20250322_e19acee5-ff33-45a5-bbbf-801756bc59b4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Danazol	DANAZOL	Teva Pharmaceuticals USA, Inc.	e19acee5-ff33-45a5-bbbf-801756bc59b4	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074582 application number: ANDA074582 ndc (product): 0555-0635

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	e19acee5-ff33-45a5-bbbf-801756bc59b4	15
197555	danazol 200 MG Oral Capsule	PSN	e19acee5-ff33-45a5-bbbf-801756bc59b4	15
197556	danazol 50 MG Oral Capsule	PSN	e19acee5-ff33-45a5-bbbf-801756bc59b4	15
197554	danazol 100 MG Oral Capsule	SCD	e19acee5-ff33-45a5-bbbf-801756bc59b4	15
197555	danazol 200 MG Oral Capsule	SCD	e19acee5-ff33-45a5-bbbf-801756bc59b4	15
197556	danazol 50 MG Oral Capsule	SCD	e19acee5-ff33-45a5-bbbf-801756bc59b4	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0635-02	00555063502	100 CAPSULE in 1 BOTTLE (0555-0635-02)	100 capsule	1996-08-09	0000-00-00	No	No	Current
0555-0635-09	00555063509	60 CAPSULE in 1 BOTTLE (0555-0635-09)	60 capsule	1996-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Danazol Capsules, USP	Teva Pharmaceuticals USA, Inc.	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	15
DANAZOL Capsules USP	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	4