Amcinonide

Product NDC
51672-4054
11-digit product format
516724054
Labeler code
51672
Product ID
51672-4054_815f3d2c-6fce-47b8-94c5-55295655cd1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amcinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA076229
Marketing category
ANDA
Marketing start
2002-05-31
Marketing end
0000-00-00
Substance
AMCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
51672-4054-1Amcinonide1 in 1 CARTONCREAM15
51672-4054-1Amcinonide15 g in 1 TUBECREAM155
51672-4054-2Amcinonide30 g in 1 TUBECREAM305
51672-4054-2Amcinonide1 in 1 CARTONCREAM15
51672-4054-3Amcinonide1 in 1 CARTONCREAM15
51672-4054-3Amcinonide60 g in 1 TUBECREAM605
51672-4054-4Amcinonide1 in 1 CARTONCREAM15
51672-4054-4Amcinonide4 g in 1 TUBECREAM45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4054-1GM - Gram51672-40545729ec78-6fa2-4b03-9262-b66548543a5512012-07-24
51672-4054-2GM - Gram51672-4054fab30b14-e780-4925-ae68-9131eeff096a12012-07-24
51672-4054-3GM - Gram51672-405420feee08-d064-4be1-9620-307416ef970d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AmcinonideACTIVE INGREDIENT423W026MA9AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
AmcinonideACTIVE MOIETY423W026MA9AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
lactic acidINACTIVE INGREDIENT33X04XA5ATAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitolINACTIVE INGREDIENT506T60A25RAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RAMCINONIDE CREAM AMCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4054AMCINONIDE CREAM AMCINONIDE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Legacy NDC, 8 package rows20250406_ac5c3e79-52f7-434e-92ae-24bd32b45edc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197327amcinonide 0.1 % Topical CreamPSNac5c3e79-52f7-434e-92ae-24bd32b45edc5
197328amcinonide 0.1 % Topical OintmentPSNac5c3e79-52f7-434e-92ae-24bd32b45edc5
197328amcinonide 0.001 MG/MG Topical OintmentSCDac5c3e79-52f7-434e-92ae-24bd32b45edc5
197327amcinonide 1 MG/ML Topical CreamSCDac5c3e79-52f7-434e-92ae-24bd32b45edc5
197327amcinonide 0.1 % Topical CreamSYac5c3e79-52f7-434e-92ae-24bd32b45edc5
197328amcinonide 0.1 % Topical OintmentSYac5c3e79-52f7-434e-92ae-24bd32b45edc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4054-1516724054011 TUBE in 1 CARTON (51672-4054-1) > 15 g in 1 TUBE1 tube2002-05-310000-00-00NoNoCurrent
51672-4054-2516724054021 TUBE in 1 CARTON (51672-4054-2) > 30 g in 1 TUBE1 tube2002-05-310000-00-00NoNoCurrent
51672-4054-3516724054031 TUBE in 1 CARTON (51672-4054-3) > 60 g in 1 TUBE1 tube2002-05-310000-00-00NoNoCurrent
51672-4054-4516724054041 TUBE in 1 CARTON (51672-4054-4) > 4 g in 1 TUBE1 tube2002-05-310000-00-00NoNoCurrent