FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0168-0268
11-digit product format
001680268
Labeler code
0168
Product ID
0168-0268_c3529d04-4942-4bba-a164-781b0e1c6fe5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone dipropionate
Dosage form
OINTMENT, AUGMENTED
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA075373
Marketing category
ANDA
Marketing start
1999-06-22
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0268-152025-08-14C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152025-08-14C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502025-08-14C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502025-08-14C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152025-07-29C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152025-07-29C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502025-07-29C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502025-07-29C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152020-09-16C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152020-09-16C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502020-09-16C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502020-09-16C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152020-07-22C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-152020-07-22C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502020-07-22C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0268-502020-07-22C16284748780-1ab0e2407-2f33-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE ointment (Augmented), 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0268-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT, AUGMENTED1513
0168-0268-50Betamethasone Dipropionate50 g in 1 TUBEOINTMENT, AUGMENTED5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0268-15GM - Gram0168-0268416ff4b0-5e8b-4a86-9e2b-649013ae1eed12013-11-04
0168-0268-50GM - Gram0168-0268cf104b78-068d-4e1e-960c-28f755cadab112013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FBETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0268BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20200917_853399f8-95a7-41f3-80e7-7ed8e3ff1a5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSN853399f8-95a7-41f3-80e7-7ed8e3ff1a5e13
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCD853399f8-95a7-41f3-80e7-7ed8e3ff1a5e13
848180augmented betamethasone 0.05 % Topical OintmentSY853399f8-95a7-41f3-80e7-7ed8e3ff1a5e13
848180betamethasone 0.05 % Augmented Topical OintmentSY853399f8-95a7-41f3-80e7-7ed8e3ff1a5e13
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSY853399f8-95a7-41f3-80e7-7ed8e3ff1a5e13
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSN018fcec3-bfb4-451c-9b54-d1fd389c2a441
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCD018fcec3-bfb4-451c-9b54-d1fd389c2a441
848180augmented betamethasone 0.05 % Topical OintmentSY018fcec3-bfb4-451c-9b54-d1fd389c2a441
848180betamethasone 0.05 % Augmented Topical OintmentSY018fcec3-bfb4-451c-9b54-d1fd389c2a441
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSY018fcec3-bfb4-451c-9b54-d1fd389c2a441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0268-150016802681515 g in 1 TUBE (0168-0268-15) 15 g1999-06-220000-00-00NoNoCurrent
0168-0268-500016802685050 g in 1 TUBE (0168-0268-50) 50 g1999-06-220000-00-00NoNoCurrent