FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
68788-7670
11-digit product format
687887670
Labeler code
68788
Product ID
68788-7670_a34fcd1d-7b6b-451e-bdc0-1c4dd75cfb38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM, AUGMENTED
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076543
Marketing category
ANDA
Marketing start
2020-02-28
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
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
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
68788-7670-5Betamethasone Dipropionate1 in 1 CARTONCREAM, AUGMENTED17
68788-7670-5Betamethasone Dipropionate50 g in 1 TUBECREAM, AUGMENTED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7670-5GM - Gram68788-76705cb56e17-7cad-460d-a2d3-3f82aedde3e712020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7670BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250209_54eff1fc-c611-4929-bb44-c1834c08f506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN54eff1fc-c611-4929-bb44-c1834c08f5067
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD54eff1fc-c611-4929-bb44-c1834c08f5067
848176augmented betamethasone 0.05 % Topical CreamSY54eff1fc-c611-4929-bb44-c1834c08f5067
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY54eff1fc-c611-4929-bb44-c1834c08f5067

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7670-5687887670051 TUBE in 1 CARTON (68788-7670-5) / 50 g in 1 TUBE1 tube2020-02-280000-00-00NoNoCurrent