FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DANAZOL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN29QWW3BUO
Rxcui197554, 197555

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
71205-862-00Danazol100 in 1 BOTTLECAPSULE1001
71205-862-30Danazol30 in 1 BOTTLECAPSULE301
71205-862-55Danazol500 in 1 BOTTLECAPSULE5001
71205-862-60Danazol60 in 1 BOTTLECAPSULE601
71205-862-72Danazol120 in 1 BOTTLECAPSULE1201
71205-862-90Danazol90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-862-00EA - Each71205-862884bad09-b8ed-48b5-8ce1-6d81798f954612022-05-04
71205-862-30EA - Each71205-8627fd42835-dca1-4169-b568-5ff887550bb612022-05-04
71205-862-55EA - Each71205-862918f2ed0-d17d-4149-b541-380b80ed37a612022-05-04
71205-862-60EA - Each71205-862ab8cc0e6-147d-4107-aab3-99a4a1d6f34712022-05-04
71205-862-72EA - Each71205-862c4a177ed-2516-4202-a284-900a32c8a63c12022-05-04
71205-862-90EA - Each71205-862465053c9-ecc5-49a5-9ca6-bcfff960b46d12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-862DANAZOL CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 6 package rows20220402_9e103cf9-f075-48ba-8913-2e44f9442781.zip

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
71205-862-0071205086200100 CAPSULE in 1 BOTTLE (71205-862-00) 100 capsule2022-04-010000-00-00NoNoCurrent
71205-862-307120508623030 CAPSULE in 1 BOTTLE (71205-862-30) 30 capsule2022-04-010000-00-00NoNoCurrent
71205-862-5571205086255500 CAPSULE in 1 BOTTLE (71205-862-55) 500 capsule2022-04-010000-00-00NoNoCurrent
71205-862-607120508626060 CAPSULE in 1 BOTTLE (71205-862-60) 60 capsule2022-04-010000-00-00NoNoCurrent
71205-862-7271205086272120 CAPSULE in 1 BOTTLE (71205-862-72) 120 capsule2022-04-010000-00-00NoNoCurrent
71205-862-907120508629090 CAPSULE in 1 BOTTLE (71205-862-90) 90 capsule2022-04-010000-00-00NoNoCurrent