FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
0168-0267
11-digit product format
001680267
Labeler code
0168
Product ID
0168-0267_5d745268-8539-4108-a0eb-444a4b1424b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
LOTION, AUGMENTED
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA077111
Marketing category
ANDA
Marketing start
2007-05-21
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/mL
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/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
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
0168-0267-302022-07-01C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-602022-07-01C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-302021-07-23C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-602021-07-23C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-302020-09-18C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-602020-09-18C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-302020-07-22C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-602020-07-22C16284748780-1ab0e2407-35ab-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0267-30Betamethasone Dipropionate30 mL in 1 BOTTLELOTION, AUGMENTED3013
0168-0267-60Betamethasone Dipropionate60 mL in 1 BOTTLELOTION, AUGMENTED6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0267-30ML - Milliliter0168-0267a8ec8087-e57e-4d0f-b520-5aa974cb087b12012-07-24
0168-0267-60ML - Milliliter0168-02672977b032-3b0c-442e-a1a2-bcaab36d2c5112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
BETAMETHASONEACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
isopropyl alcoholINACTIVE INGREDIENTND2M416302BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
betamethasone dipropionateACTIVE MOIETY826Y60901UBETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PBETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
phosphoric acidINACTIVE INGREDIENTE4GA8884NNBETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWBETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0267BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 2 package rows20220702_4f411e41-00dc-47cf-8517-3ff5876e1bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionPSN4f411e41-00dc-47cf-8517-3ff5876e1bf513
848178Augmented betamethasone 0.5 MG/ML Topical LotionSCD4f411e41-00dc-47cf-8517-3ff5876e1bf513
848178augmented betamethasone 0.05 % Topical LotionSY4f411e41-00dc-47cf-8517-3ff5876e1bf513
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionSY4f411e41-00dc-47cf-8517-3ff5876e1bf513
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionPSN90d6c26b-3623-477e-afca-7028587bdf802
848178Augmented betamethasone 0.5 MG/ML Topical LotionSCD90d6c26b-3623-477e-afca-7028587bdf802
848178augmented betamethasone 0.05 % Topical LotionSY90d6c26b-3623-477e-afca-7028587bdf802
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionSY90d6c26b-3623-477e-afca-7028587bdf802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0267-300016802673030 mL in 1 BOTTLE (0168-0267-30) 30 ml2007-05-210000-00-00NoNoCurrent
0168-0267-600016802676060 mL in 1 BOTTLE (0168-0267-60) 60 ml2007-05-210000-00-00NoNoCurrent