Home NDC 62135-476 Danazol
Product NDC 62135-476
11-digit product format 621350476
Labeler code 62135
Product ID 62135-476_241f23e1-4b4b-4adb-e063-6394a90adcc5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Danazol
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA077246
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 · 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-476-60 Danazol 60 in 1 BOTTLE CAPSULE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-476 DANAZOL CAPSULE [CHARTWELL RX, LLC.] 3 Current NDC, 1 package rows 20241012_55ad6325-16f6-4f0c-a1dc-734847052d0b.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 Sample Exclude flag Status 62135-476-60 62135047660 60 CAPSULE in 1 BOTTLE (62135-476-60) 60 capsule 2023-02-27 No No Current