Amcinonide

Product NDC
51672-4060
11-digit product format
516724060
Labeler code
51672
Product ID
51672-4060_31e404cb-aac7-730b-e063-6394a90afc03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amcinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076367
Marketing category
ANDA
Marketing start
2003-03-19
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, 197328

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
51672-4060-1Amcinonide1 in 1 CARTONOINTMENT15
51672-4060-1Amcinonide15 g in 1 TUBEOINTMENT155
51672-4060-2Amcinonide30 g in 1 TUBEOINTMENT305
51672-4060-2Amcinonide1 in 1 CARTONOINTMENT15
51672-4060-3Amcinonide1 in 1 CARTONOINTMENT15
51672-4060-3Amcinonide60 g in 1 TUBEOINTMENT605

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
51672-4060AMCINONIDE CREAM AMCINONIDE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 6 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
51672-4060-1516724060011 TUBE in 1 CARTON (51672-4060-1) / 15 g in 1 TUBE1 tube2003-03-190000-00-00NoNoCurrent
51672-4060-2516724060021 TUBE in 1 CARTON (51672-4060-2) / 30 g in 1 TUBE1 tube2003-03-190000-00-00NoNoCurrent
51672-4060-3516724060031 TUBE in 1 CARTON (51672-4060-3) / 60 g in 1 TUBE1 tube2003-03-190000-00-00NoNoCurrent