Home NDC 0527-1369 Danazol
Product NDC 0527-1369
11-digit product format 005271369
Labeler code 0527
Product ID 0527-1369_399a377e-237d-4939-ad70-805ebd30a1c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Danazol
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
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 · 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 0527-1369-01 Danazol 100 in 1 BOTTLE CAPSULE 100 28 0527-1369-06 Danazol 60 in 1 BOTTLE CAPSULE 60 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 DANAZOL ACTIVE INGREDIENT N29QWW3BUO DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 DANAZOL ACTIVE MOIETY N29QWW3BUO DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DANAZOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1369 DANAZOL CAPSULE [LANNETT COMPANY, INC.] 28 Current NDC, Legacy NDC, 2 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 · 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 0527-1369-01 00527136901 100 CAPSULE in 1 BOTTLE (0527-1369-01) 100 capsule 2005-09-28 0000-00-00 No No Current 0527-1369-06 00527136906 60 CAPSULE in 1 BOTTLE (0527-1369-06) 60 capsule 2005-09-28 0000-00-00 No No Current