FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0472-0381
11-digit product format
004720381
Labeler code
0472
Product ID
0472-0381_e8e8285a-02b1-4e44-baf1-459545f7a631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA071012
Marketing category
ANDA
Marketing start
1997-02-01
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
Rxcui197405

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
0472-0381-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT1512
0472-0381-15Betamethasone Dipropionate1 in 1 CARTONOINTMENT112
0472-0381-45Betamethasone Dipropionate45 g in 1 TUBEOINTMENT4512
0472-0381-45Betamethasone Dipropionate1 in 1 CARTONOINTMENT112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0381-15GM - Gram0472-0381049c6ec4-1cdb-4dcd-8844-428bae53322f12013-02-11
0472-0381-45GM - Gram0472-0381e0268e59-27bd-4650-ba14-63e8e97c92f812013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE OINTMENT [ACTAVIS MID ATLANTIC LLC]2
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0381BETAMETHASONE DIPROPIONATE OINTMENT [ACTAVIS PHARMA, INC.]12Current NDC, Legacy NDC, 4 package rows20230525_aa3f4012-7597-422d-8bcc-00102780a152.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197405betamethasone dipropionate 0.05 % Topical OintmentPSNaa3f4012-7597-422d-8bcc-00102780a15212
197405betamethasone 0.0005 MG/MG Topical OintmentSCDaa3f4012-7597-422d-8bcc-00102780a15212
197405betamethasone 0.05 % Topical OintmentSYaa3f4012-7597-422d-8bcc-00102780a15212
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSYaa3f4012-7597-422d-8bcc-00102780a15212
197405betamethasone dipropionate 0.05 % Topical OintmentPSN389cdebb-55fe-4808-a5b7-0f293d9ee45d1
197405betamethasone 0.0005 MG/MG Topical OintmentSCD389cdebb-55fe-4808-a5b7-0f293d9ee45d1
197405betamethasone 0.05 % Topical OintmentSY389cdebb-55fe-4808-a5b7-0f293d9ee45d1
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY389cdebb-55fe-4808-a5b7-0f293d9ee45d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0381-15004720381151 TUBE in 1 CARTON (0472-0381-15) / 15 g in 1 TUBE1 tube1997-02-010000-00-00NoNoCurrent
0472-0381-45004720381451 TUBE in 1 CARTON (0472-0381-45) / 45 g in 1 TUBE1 tube1997-02-010000-00-00NoNoCurrent