Amcinonide

Product NDC
74157-006
11-digit product format
741570006
Labeler code
74157
Product ID
74157-006_395847bf-ef5e-ef2a-e063-6294a90acf3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amcinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
INA PHARMACEUTICS INC.
Application
ANDA076229
Marketing category
ANDA
Marketing start
2024-05-09
Substance
AMCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMCINONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii423W026MA9
Rxcui197327

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0fb13bea-60d5-d576-4a84-8309e25165c0Product name120140508
c0873041-d18b-ad0e-0adf-75965d870ba7Product name120140508
c8da84f8-c4bb-d0f3-daba-c86a13a1d1c9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74157-006-60Amcinonide60 g in 1 TUBECREAM603
74157-006-60Amcinonide1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
74157-006-60GM - Gram74157-006a61c5432-3726-4199-b334-3df29060ecca12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74157-006AMCINONIDE CREAM [INA PHARMACEUTICS INC.]2Current NDC, 2 package rows20240516_e7dc754e-eeff-4c30-a52a-629c72ad2415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197327amcinonide 0.1 % Topical CreamPSNe7dc754e-eeff-4c30-a52a-629c72ad24153
197327amcinonide 1 MG/ML Topical CreamSCDe7dc754e-eeff-4c30-a52a-629c72ad24153
197327amcinonide 0.1 % Topical CreamSYe7dc754e-eeff-4c30-a52a-629c72ad24153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
74157-006-60741570006601 TUBE in 1 CARTON (74157-006-60) / 60 g in 1 TUBE1 tube2024-05-09NoNoHistorical