FDA.reportPublic FDA data

Danazol

Product NDC
71205-861
11-digit product format
712050861
Labeler code
71205
Product ID
71205-861_9e103cf9-f075-48ba-8913-2e44f9442781
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Danazol
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078214
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.

Additional Listing Data#

Finished product
Yes
Brand name base
Danazol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DANAZOL100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N29QWW3BUOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197554Internal RxNorm lookup
197555Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e103cf9-f075-48ba-8913-2e44f9442781Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75693c89-6d89-3c6a-9c3f-cbfd21877b44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-861-00Danazol100 in 1 BOTTLECAPSULE1001
71205-861-30Danazol30 in 1 BOTTLECAPSULE301
71205-861-55Danazol500 in 1 BOTTLECAPSULE5001
71205-861-60Danazol60 in 1 BOTTLECAPSULE601
71205-861-72Danazol120 in 1 BOTTLECAPSULE1201
71205-861-90Danazol90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-861-00EA - Each71205-8619e6da5eb-e98a-4c87-ba09-933b0e13cb2112022-05-04
71205-861-30EA - Each71205-8612a8705c7-43b0-4d81-b53e-f316313ac32512022-05-04
71205-861-55EA - Each71205-861e3a1171d-8f18-4cf6-a321-e49adc6c2ffb12022-05-04
71205-861-60EA - Each71205-861b8e4e9dc-66e1-4d4f-a38f-7ddf8525297912022-05-04
71205-861-72EA - Each71205-861f25ced68-b3bb-49a4-a1ac-e4ebeb2237b312022-05-04
71205-861-90EA - Each71205-861315365d2-a81e-4f2a-97ec-8e5a6ab9b12e12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-861DANAZOL CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 6 package rows20220402_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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DanazolDANAZOLProficient Rx LP9e103cf9-f075-48ba-8913-2e44f94427812022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078214
application number: ANDA078214
ndc (product): 71205-861
DanazolDANAZOLLannett Company, Inc.f2c9b713-aafc-49ca-866e-334d9b5c2e2d2020-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078214
application number: ANDA078214

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197554danazol 100 MG Oral CapsulePSN9e103cf9-f075-48ba-8913-2e44f94427811
197555danazol 200 MG Oral CapsulePSN9e103cf9-f075-48ba-8913-2e44f94427811
197554danazol 100 MG Oral CapsuleSCD9e103cf9-f075-48ba-8913-2e44f94427811
197555danazol 200 MG Oral CapsuleSCD9e103cf9-f075-48ba-8913-2e44f94427811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-861-0071205086100100 CAPSULE in 1 BOTTLE (71205-861-00) 100 capsule2022-04-010000-00-00NoNoCurrent
71205-861-307120508613030 CAPSULE in 1 BOTTLE (71205-861-30) 30 capsule2022-04-010000-00-00NoNoCurrent
71205-861-5571205086155500 CAPSULE in 1 BOTTLE (71205-861-55) 500 capsule2022-04-010000-00-00NoNoCurrent
71205-861-607120508616060 CAPSULE in 1 BOTTLE (71205-861-60) 60 capsule2022-04-010000-00-00NoNoCurrent
71205-861-7271205086172120 CAPSULE in 1 BOTTLE (71205-861-72) 120 capsule2022-04-010000-00-00NoNoCurrent
71205-861-907120508619090 CAPSULE in 1 BOTTLE (71205-861-90) 90 capsule2022-04-010000-00-00NoNoCurrent