FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
51672-1310
11-digit product format
516721310
Labeler code
51672
Product ID
51672-1310_3fb723a8-70e1-d700-e063-6294a90a53c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM, AUGMENTED
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076543
Marketing category
ANDA
Marketing start
2003-12-09
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 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
Betamethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui848176

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1310-1Betamethasone Dipropionate1 in 1 CARTONCREAM, AUGMENTED18
51672-1310-1Betamethasone Dipropionate15 g in 1 TUBECREAM, AUGMENTED158
51672-1310-2Betamethasone Dipropionate30 g in 1 TUBECREAM, AUGMENTED308
51672-1310-2Betamethasone Dipropionate1 in 1 CARTONCREAM, AUGMENTED18
51672-1310-3Betamethasone Dipropionate1 in 1 CARTONCREAM, AUGMENTED18
51672-1310-3Betamethasone Dipropionate50 g in 1 TUBECREAM, AUGMENTED508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1310-1GM - Gram51672-13101a93637d-5b1c-4b88-9f5f-b66de807912812012-07-24
51672-1310-3GM - Gram51672-13105ea95523-9dc9-4f02-b6db-3e4cf8febea312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27EBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
ceteareth-30INACTIVE INGREDIENT1R9DCZ5FOXBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
chlorocresolINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
cyclomethiconeINACTIVE INGREDIENTNMQ347994ZBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl oleateINACTIVE INGREDIENT4PC054V79PBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitolINACTIVE INGREDIENT506T60A25RBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FBETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1310BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20210415_000ae256-a337-4903-845b-003777a4efa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSNabd5a08c-4bb7-46c9-9e2e-0a89c43d46c89
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCDabd5a08c-4bb7-46c9-9e2e-0a89c43d46c89
848176augmented betamethasone 0.05 % Topical CreamSYabd5a08c-4bb7-46c9-9e2e-0a89c43d46c89
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSYabd5a08c-4bb7-46c9-9e2e-0a89c43d46c89
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN000ae256-a337-4903-845b-003777a4efa88
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD000ae256-a337-4903-845b-003777a4efa88
848176augmented betamethasone 0.05 % Topical CreamSY000ae256-a337-4903-845b-003777a4efa88
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY000ae256-a337-4903-845b-003777a4efa88
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN54eff1fc-c611-4929-bb44-c1834c08f5067
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD54eff1fc-c611-4929-bb44-c1834c08f5067
848176augmented betamethasone 0.05 % Topical CreamSY54eff1fc-c611-4929-bb44-c1834c08f5067
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY54eff1fc-c611-4929-bb44-c1834c08f5067
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN75862805-2cfc-fb45-e053-2991aa0a14035
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD75862805-2cfc-fb45-e053-2991aa0a14035
848176augmented betamethasone 0.05 % Topical CreamSY75862805-2cfc-fb45-e053-2991aa0a14035
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY75862805-2cfc-fb45-e053-2991aa0a14035
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSNa87f6527-7503-4333-b928-5226a5eb0b8d3
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCDa87f6527-7503-4333-b928-5226a5eb0b8d3
848176augmented betamethasone 0.05 % Topical CreamSYa87f6527-7503-4333-b928-5226a5eb0b8d3
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSYa87f6527-7503-4333-b928-5226a5eb0b8d3
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN86994546-929c-4303-89e4-31ba271673cf1
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD86994546-929c-4303-89e4-31ba271673cf1
848176augmented betamethasone 0.05 % Topical CreamSY86994546-929c-4303-89e4-31ba271673cf1
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY86994546-929c-4303-89e4-31ba271673cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1310-1516721310011 TUBE in 1 CARTON (51672-1310-1) / 15 g in 1 TUBE1 tube2003-12-090000-00-00NoNoCurrent
51672-1310-2516721310021 TUBE in 1 CARTON (51672-1310-2) / 30 g in 1 TUBE1 tube2003-12-090000-00-00NoNoCurrent
51672-1310-3516721310031 TUBE in 1 CARTON (51672-1310-3) / 50 g in 1 TUBE1 tube2003-12-090000-00-00NoNoCurrent