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

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 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
71205-861-00Danazol100 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

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