FDA.reportPublic FDA data

BETAMETHASONE DIPROPIONATE

Product NDC
35573-107
11-digit product format
355730107
Labeler code
35573
Product ID
35573-107_c8bda9a8-4dec-4084-84e5-4b4623390bd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BETAMETHASONE DIPROPIONATE
Dosage form
OINTMENT, AUGMENTED
Route
TOPICAL
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA218289
Marketing category
ANDA
Marketing start
2025-01-15
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
Rxcui848180

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
35573-107-15BETAMETHASONE DIPROPIONATE1 in 1 CARTONOINTMENT, AUGMENTED11
35573-107-15BETAMETHASONE DIPROPIONATE15 g in 1 TUBEOINTMENT, AUGMENTED151
35573-107-49BETAMETHASONE DIPROPIONATE1 in 1 CARTONOINTMENT, AUGMENTED11
35573-107-49BETAMETHASONE DIPROPIONATE50 g in 1 TUBEOINTMENT, AUGMENTED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-107BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [BUREL PHARMACEUTICALS, LLC]1Current NDC, 4 package rows20250115_c8bda9a8-4dec-4084-84e5-4b4623390bd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSNc8bda9a8-4dec-4084-84e5-4b4623390bd81
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCDc8bda9a8-4dec-4084-84e5-4b4623390bd81
848180augmented betamethasone 0.05 % Topical OintmentSYc8bda9a8-4dec-4084-84e5-4b4623390bd81
848180betamethasone 0.05 % Augmented Topical OintmentSYc8bda9a8-4dec-4084-84e5-4b4623390bd81
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSYc8bda9a8-4dec-4084-84e5-4b4623390bd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35573-107-15355730107151 TUBE in 1 CARTON (35573-107-15) / 15 g in 1 TUBE1 tube2025-01-15NoNoCurrent
35573-107-49355730107491 TUBE in 1 CARTON (35573-107-49) / 50 g in 1 TUBE1 tube2025-01-15NoNoCurrent