FDA.reportPublic FDA data

Betamethasone dipropionate

Product NDC
50090-4680
11-digit product format
500904680
Labeler code
50090
Product ID
50090-4680_38ac25fc-2057-49f3-aa92-5e81e0416bcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA208885
Marketing category
ANDA
Marketing start
2019-02-26
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
Rxcui238920

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
50090-4680-02023-02-07C16284748780-1f386c64a-26e4-0266-e053-dadaa90a7c1aBetamethasone Dipropionate Cream USP, 0.05% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
50090-4680-02023-01-30C16284748780-1f386c64a-26e4-0266-e053-dadaa90a7c1aBetamethasone Dipropionate Cream USP, 0.05% (Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4680-0Betamethasone dipropionate1 in 1 CARTONCREAM18
50090-4680-0Betamethasone dipropionate45 g in 1 TUBECREAM458

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4680-0GM - Gram50090-468043003a95-86a8-4904-bf7f-3fbf7c67135212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4680BETAMETHASONE DIPROPIONATE CREAM [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20231101_1c15cbe5-51d6-4a1a-bb42-811f1d84ae66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSN1c15cbe5-51d6-4a1a-bb42-811f1d84ae668
238920betamethasone 0.5 MG/ML Topical CreamSCD1c15cbe5-51d6-4a1a-bb42-811f1d84ae668
238920betamethasone 0.05 % Topical CreamSY1c15cbe5-51d6-4a1a-bb42-811f1d84ae668
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY1c15cbe5-51d6-4a1a-bb42-811f1d84ae668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4680-0500904680001 TUBE in 1 CARTON (50090-4680-0) / 45 g in 1 TUBE1 tube2019-11-040000-00-00NoNoCurrent