FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
21922-104
11-digit product format
219220104
Labeler code
21922
Product ID
21922-104_cb91d996-4591-4ff4-8468-186aa4f7d837
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BETAMETHASONE DIPROPIONATE
Dosage form
LOTION, AUGMENTED
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA206389
Marketing category
ANDA
Marketing start
2025-11-25
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/mL
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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui848178

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-104-01Betamethasone Dipropionate60 mL in 1 BOTTLE, PLASTICLOTION, AUGMENTED602
21922-104-01Betamethasone Dipropionate1 in 1 CARTONLOTION, AUGMENTED12
21922-104-21Betamethasone Dipropionate1 in 1 CARTONLOTION, AUGMENTED12
21922-104-21Betamethasone Dipropionate30 mL in 1 BOTTLE, PLASTICLOTION, AUGMENTED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-104-01ML - Milliliter21922-104efb265d6-2174-413c-a102-0bb3e8625ff512026-03-17
21922-104-21ML - Milliliter21922-104d05f349a-068f-46f9-a8e1-d98e10ec4abc12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionPSN7e946599-2fb4-4426-bb59-fbb71d89dac82
848178Augmented betamethasone 0.5 MG/ML Topical LotionSCD7e946599-2fb4-4426-bb59-fbb71d89dac82
848178augmented betamethasone 0.05 % Topical LotionSY7e946599-2fb4-4426-bb59-fbb71d89dac82
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionSY7e946599-2fb4-4426-bb59-fbb71d89dac82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
21922-104-01219220104011 BOTTLE, PLASTIC in 1 CARTON (21922-104-01) / 60 mL in 1 BOTTLE, PLASTIC2025-11-25NoNoCurrent
21922-104-21219220104211 BOTTLE, PLASTIC in 1 CARTON (21922-104-21) / 30 mL in 1 BOTTLE, PLASTIC2025-11-25NoNoCurrent