Home NDC 42291-243-01 Danazol
Product NDC 42291-243
Requested package NDC 42291-243-01
11-digit product format 422910243
Labeler code 42291
Product ID 42291-243_d57a0a79-c3c5-3000-e053-2995a90a7c25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Danazol
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA074582
Marketing category ANDA
Marketing start 2016-02-23
Marketing end 0000-00-00
Substance DANAZOL
Active strength 200 mg/1
Pharmacologic classes Androgen Receptor Agonists [MoA],Androstanes [CS],Androgen [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-243-01 42291024301 100 CAPSULE in 1 BOTTLE (42291-243-01) 100 capsule 2016-02-23 0000-00-00 No No Current