FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0168-0055
11-digit product format
001680055
Labeler code
0168
Product ID
0168-0055_3a499a57-9faa-419d-beeb-3aba6b8c2d7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
NDA019137
Marketing category
NDA
Marketing start
1984-06-26
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
0168-0055-15Betamethasone Dipropionate15 g in 1 TUBECREAM1512
0168-0055-15Betamethasone Dipropionate1 in 1 CARTONCREAM112
0168-0055-46Betamethasone Dipropionate1 in 1 CARTONCREAM112
0168-0055-46Betamethasone Dipropionate45 g in 1 TUBECREAM4512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0055-15GM - Gram0168-00550e10c001-8e77-4660-85f2-2843afd8818a12012-07-24
0168-0055-46GM - Gram0168-00550df53f2f-f261-43d1-8c1f-6e11e534630112012-07-24

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
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [H.J. HARKINS COMPANY, INC.]3
betamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [H.J. HARKINS COMPANY, INC.]3
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
betamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
ceteth-20INACTIVE INGREDIENTI835H2IHHXBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
chlorocresolINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
sodium phosphate, monobasic, monohydrateINACTIVE INGREDIENT593YOG76RNBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0055BETAMETHASONE 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
238920betamethasone 0.05 % Topical CreamPSNfe946b6d-2b6d-490b-8d63-c865e1c4332126
238920betamethasone 0.5 MG/ML Topical CreamSCDfe946b6d-2b6d-490b-8d63-c865e1c4332126
238920betamethasone 0.05 % Topical CreamSYfe946b6d-2b6d-490b-8d63-c865e1c4332126
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYfe946b6d-2b6d-490b-8d63-c865e1c4332126
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
238920betamethasone 0.05 % Topical CreamPSN668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.5 MG/ML Topical CreamSCD668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.05 % Topical CreamSY668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY668279da-ff19-47c9-84f7-267d27ad34f83
238920betamethasone 0.05 % Topical CreamPSN7cacf0ec-3db9-48be-9a76-93ed4a1f042c2
238920betamethasone 0.5 MG/ML Topical CreamSCD7cacf0ec-3db9-48be-9a76-93ed4a1f042c2
238920betamethasone 0.05 % Topical CreamSY7cacf0ec-3db9-48be-9a76-93ed4a1f042c2
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY7cacf0ec-3db9-48be-9a76-93ed4a1f042c2
238920betamethasone 0.05 % Topical CreamPSN7ca6552c-bd9f-4630-b202-38dea8b7d9941
238920betamethasone 0.5 MG/ML Topical CreamSCD7ca6552c-bd9f-4630-b202-38dea8b7d9941
238920betamethasone 0.05 % Topical CreamSY7ca6552c-bd9f-4630-b202-38dea8b7d9941
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY7ca6552c-bd9f-4630-b202-38dea8b7d9941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0055-15001680055151 TUBE in 1 CARTON (0168-0055-15) / 15 g in 1 TUBE1 tube1984-06-260000-00-00NoNoCurrent
0168-0055-46001680055461 TUBE in 1 CARTON (0168-0055-46) / 45 g in 1 TUBE1 tube1984-06-260000-00-00NoNoCurrent