FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
68071-4556
11-digit product format
680714556
Labeler code
68071
Product ID
68071-4556_31e29202-2082-bc70-e063-6394a90afee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM, AUGMENTED
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076543
Marketing category
ANDA
Marketing start
2003-12-09
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4556-52024-06-10C16284748780-1ba0f9c33-26aa-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE CREAM (augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE CREAM (augmented). BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1983
68071-4556-52023-01-30C16284748780-1ba0f9c33-26aa-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE CREAM (augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE CREAM (augmented). BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1983
68071-4556-52021-02-19C16284748780-1ba0f9c33-26aa-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE CREAM (augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE CREAM (augmented). BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1983
68071-4556-52021-01-29C16284748780-1ba0f9c33-26aa-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE CREAM (augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE CREAM (augmented). BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4556-3Betamethasone Dipropionate30 g in 1 BOXCREAM, AUGMENTED305
68071-4556-5Betamethasone Dipropionate15 g in 1 BOXCREAM, AUGMENTED155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4556BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20250406_75862805-2cfc-fb45-e053-2991aa0a1403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN75862805-2cfc-fb45-e053-2991aa0a14035
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD75862805-2cfc-fb45-e053-2991aa0a14035
848176augmented betamethasone 0.05 % Topical CreamSY75862805-2cfc-fb45-e053-2991aa0a14035
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY75862805-2cfc-fb45-e053-2991aa0a14035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4556-36807145560330 g in 1 BOX (68071-4556-3) 30 g2018-09-10NoNoCurrent
68071-4556-56807145560515 g in 1 BOX (68071-4556-5) 15 g2018-09-100000-00-00NoNoCurrent