FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
63629-8614
11-digit product format
636298614
Labeler code
63629
Product ID
63629-8614_8cf308aa-053b-44d9-b294-c33f70c03524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA076592
Marketing category
ANDA
Marketing start
2006-09-28
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
Rxcui848176

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
63629-8614-1Betamethasone Dipropionate1 in 1 CARTONCREAM1103
63629-8614-1Betamethasone Dipropionate50 g in 1 TUBECREAM50103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8614-1GM - Gram63629-861498937b9c-0848-482e-8147-14be6176155a12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8614BETAMETHASONE DIPROPIONATE CREAM [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240113_79256f36-adff-4628-abc5-cb25bdfdc19d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN79256f36-adff-4628-abc5-cb25bdfdc19d103
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD79256f36-adff-4628-abc5-cb25bdfdc19d103
848176augmented betamethasone 0.05 % Topical CreamSY79256f36-adff-4628-abc5-cb25bdfdc19d103
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY79256f36-adff-4628-abc5-cb25bdfdc19d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8614-1636298614011 TUBE in 1 CARTON (63629-8614-1) / 50 g in 1 TUBE1 tube2021-07-090000-00-00NoNoCurrent