Home NDC 71205-862 Danazol
Product NDC 71205-862
11-digit product format 712050862
Labeler code 71205
Product ID 71205-862_9e103cf9-f075-48ba-8913-2e44f9442781
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Danazol
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
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 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 A077246-001 DANAZOL DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 A077246-002 DANAZOL DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 A077246-003 DANAZOL DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19
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 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077246-002 DANAZOL 50MG CAPSULE / ORAL AB 2007-04-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077246-003 DANAZOL 100MG CAPSULE / ORAL AB 2007-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077246-001 DANAZOL 200MG CAPSULE / ORAL AB 2005-09-28 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197554 Internal RxNorm lookup 197555 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-862 DANAZOL CAPSULE [PROFICIENT RX LP] 1 Current NDC, Legacy NDC, 6 package rows 20220402_9e103cf9-f075-48ba-8913-2e44f9442781.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71205-862-00 71205086200 100 CAPSULE in 1 BOTTLE (71205-862-00) 100 capsule 2022-04-01 0000-00-00 No No Current 71205-862-30 71205086230 30 CAPSULE in 1 BOTTLE (71205-862-30) 30 capsule 2022-04-01 0000-00-00 No No Current 71205-862-55 71205086255 500 CAPSULE in 1 BOTTLE (71205-862-55) 500 capsule 2022-04-01 0000-00-00 No No Current 71205-862-60 71205086260 60 CAPSULE in 1 BOTTLE (71205-862-60) 60 capsule 2022-04-01 0000-00-00 No No Current 71205-862-72 71205086272 120 CAPSULE in 1 BOTTLE (71205-862-72) 120 capsule 2022-04-01 0000-00-00 No No Current 71205-862-90 71205086290 90 CAPSULE in 1 BOTTLE (71205-862-90) 90 capsule 2022-04-01 0000-00-00 No No Current