FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0472-0382
11-digit product format
004720382
Labeler code
0472
Product ID
0472-0382_2f2016cb-8b63-40ef-ad6d-4850179ec8cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
OINTMENT, AUGMENTED
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074304
Marketing category
ANDA
Marketing start
1995-09-01
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
Rxcui848180

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
0472-0382-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT, AUGMENTED1521
0472-0382-15Betamethasone Dipropionate1 in 1 CARTONOINTMENT, AUGMENTED121
0472-0382-45Betamethasone Dipropionate45 g in 1 TUBEOINTMENT, AUGMENTED4521
0472-0382-45Betamethasone Dipropionate1 in 1 CARTONOINTMENT, AUGMENTED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0382-15GM - Gram0472-03823e51766a-38bb-4ea9-ad43-1c4f9bc96f3e12013-02-13
0472-0382-45GM - Gram0472-038219716fea-f3b5-473d-a633-39018b316f1212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS MID ATLANTIC LLC]3
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS MID ATLANTIC LLC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS MID ATLANTIC LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS MID ATLANTIC LLC]3
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS MID ATLANTIC LLC]3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS MID ATLANTIC LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0382BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 4 package rows20230621_af8317d7-b280-4f40-ad88-802f99d33d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSNaf8317d7-b280-4f40-ad88-802f99d33d7821
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCDaf8317d7-b280-4f40-ad88-802f99d33d7821
848180augmented betamethasone 0.05 % Topical OintmentSYaf8317d7-b280-4f40-ad88-802f99d33d7821
848180betamethasone 0.05 % Augmented Topical OintmentSYaf8317d7-b280-4f40-ad88-802f99d33d7821
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSYaf8317d7-b280-4f40-ad88-802f99d33d7821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0382-15004720382151 TUBE in 1 CARTON (0472-0382-15) / 15 g in 1 TUBE1 tube1995-09-010000-00-00NoNoCurrent
0472-0382-45004720382451 TUBE in 1 CARTON (0472-0382-45) / 45 g in 1 TUBE1 tube1995-09-010000-00-00NoNoCurrent