FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0472-0380
11-digit product format
004720380
Labeler code
0472
Product ID
0472-0380_c08077cb-b3a1-4bd8-85ba-731e73cc66e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070885
Marketing category
ANDA
Marketing start
2002-09-03
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
Rxcui238920

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-0380-15Betamethasone Dipropionate1 in 1 CARTONCREAM112
0472-0380-15Betamethasone Dipropionate15 g in 1 TUBECREAM1512
0472-0380-45Betamethasone Dipropionate1 in 1 CARTONCREAM112
0472-0380-45Betamethasone Dipropionate45 g in 1 TUBECREAM4512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0380-15GM - Gram0472-0380d0f9b3c5-791c-4490-ab58-9b3ad82318ed12013-02-11
0472-0380-45GM - Gram0472-038042eaf09a-b188-47ca-9af4-d2bea05f92f412013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWBETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0380BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 4 package rows20250328_ab332791-461b-4396-9b46-7f00bc04c087.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSNab332791-461b-4396-9b46-7f00bc04c08712
238920betamethasone 0.5 MG/ML Topical CreamSCDab332791-461b-4396-9b46-7f00bc04c08712
238920betamethasone 0.05 % Topical CreamSYab332791-461b-4396-9b46-7f00bc04c08712
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYab332791-461b-4396-9b46-7f00bc04c08712
238920betamethasone 0.05 % Topical CreamPSN4a2fc75a-70d3-4c42-8001-19ac91b3d0eb11
238920betamethasone 0.5 MG/ML Topical CreamSCD4a2fc75a-70d3-4c42-8001-19ac91b3d0eb11
238920betamethasone 0.05 % Topical CreamSY4a2fc75a-70d3-4c42-8001-19ac91b3d0eb11
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY4a2fc75a-70d3-4c42-8001-19ac91b3d0eb11
238920betamethasone 0.05 % Topical CreamPSN0aaa5de4-442b-4184-8378-ea47831e96637
238920betamethasone 0.5 MG/ML Topical CreamSCD0aaa5de4-442b-4184-8378-ea47831e96637
238920betamethasone 0.05 % Topical CreamSY0aaa5de4-442b-4184-8378-ea47831e96637
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY0aaa5de4-442b-4184-8378-ea47831e96637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0380-15004720380151 TUBE in 1 CARTON (0472-0380-15) / 15 g in 1 TUBE1 tube2002-09-030000-00-00NoNoCurrent
0472-0380-45004720380451 TUBE in 1 CARTON (0472-0380-45) / 45 g in 1 TUBE1 tube2002-09-030000-00-00NoNoCurrent