FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0168-0056
11-digit product format
001680056
Labeler code
0168
Product ID
0168-0056_3a499a57-9faa-419d-beeb-3aba6b8c2d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
NDA019141
Marketing category
NDA
Marketing start
1984-09-04
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Betamethasone Dipropionate
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui197405, 238920, 240209

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0056-15Betamethasone Dipropionate1 in 1 CARTONOINTMENT112
0168-0056-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT1512
0168-0056-46Betamethasone Dipropionate1 in 1 CARTONOINTMENT112
0168-0056-46Betamethasone Dipropionate45 g in 1 TUBEOINTMENT4512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0056-15GM - Gram0168-0056571d6be4-75b6-4af3-bb92-531af802ebdf12012-07-24
0168-0056-46GM - Gram0168-0056cca348bb-28f4-4f19-997b-2268ecdbbdf212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
betamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CETETH-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
CETETH-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0056BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 4 package rows20220202_97dde5f5-a865-4af2-b562-8da72c8475f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197405betamethasone dipropionate 0.05 % Topical OintmentPSN7da1c732-3477-4031-b776-149bd5ceea2724
197405betamethasone 0.0005 MG/MG Topical OintmentSCD7da1c732-3477-4031-b776-149bd5ceea2724
197405betamethasone 0.05 % Topical OintmentSY7da1c732-3477-4031-b776-149bd5ceea2724
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY7da1c732-3477-4031-b776-149bd5ceea2724
238920betamethasone 0.05 % Topical CreamPSN97dde5f5-a865-4af2-b562-8da72c8475f312
240209betamethasone dipropionate 0.05 % Topical LotionPSN97dde5f5-a865-4af2-b562-8da72c8475f312
197405betamethasone dipropionate 0.05 % Topical OintmentPSN97dde5f5-a865-4af2-b562-8da72c8475f312
197405betamethasone 0.0005 MG/MG Topical OintmentSCD97dde5f5-a865-4af2-b562-8da72c8475f312
238920betamethasone 0.5 MG/ML Topical CreamSCD97dde5f5-a865-4af2-b562-8da72c8475f312
240209betamethasone 0.5 MG/ML Topical LotionSCD97dde5f5-a865-4af2-b562-8da72c8475f312
238920betamethasone 0.05 % Topical CreamSY97dde5f5-a865-4af2-b562-8da72c8475f312
240209betamethasone 0.05 % Topical LotionSY97dde5f5-a865-4af2-b562-8da72c8475f312
197405betamethasone 0.05 % Topical OintmentSY97dde5f5-a865-4af2-b562-8da72c8475f312
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY97dde5f5-a865-4af2-b562-8da72c8475f312
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY97dde5f5-a865-4af2-b562-8da72c8475f312
240209betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Topical LotionSY97dde5f5-a865-4af2-b562-8da72c8475f312
238920betamethasone 0.05 % Topical CreamPSNdc35ba25-8746-4ed8-83c1-e6b6a10578635
197405betamethasone dipropionate 0.05 % Topical OintmentPSNdc35ba25-8746-4ed8-83c1-e6b6a10578635
197405betamethasone 0.0005 MG/MG Topical OintmentSCDdc35ba25-8746-4ed8-83c1-e6b6a10578635
238920betamethasone 0.5 MG/ML Topical CreamSCDdc35ba25-8746-4ed8-83c1-e6b6a10578635
238920betamethasone 0.05 % Topical CreamSYdc35ba25-8746-4ed8-83c1-e6b6a10578635
197405betamethasone 0.05 % Topical OintmentSYdc35ba25-8746-4ed8-83c1-e6b6a10578635
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYdc35ba25-8746-4ed8-83c1-e6b6a10578635
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSYdc35ba25-8746-4ed8-83c1-e6b6a10578635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0056-15001680056151 TUBE in 1 CARTON (0168-0056-15) / 15 g in 1 TUBE1 tube1984-09-040000-00-00NoNoCurrent
0168-0056-46001680056461 TUBE in 1 CARTON (0168-0056-46) / 45 g in 1 TUBE1 tube1984-09-040000-00-00NoNoCurrent