FDA.reportPublic FDA data

Betamethasone dipropionate

Product NDC
68180-947
11-digit product format
681800947
Labeler code
68180
Product ID
68180-947_fb870496-75f5-4f2a-a156-2552d9c13e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone dipropionate
Dosage form
OINTMENT, AUGMENTED
Route
TOPICAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA209106
Marketing category
ANDA
Marketing start
2020-03-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-947-01Betamethasone dipropionate1 in 1 CARTONOINTMENT, AUGMENTED19
68180-947-01Betamethasone dipropionate15 g in 1 TUBEOINTMENT, AUGMENTED159
68180-947-02Betamethasone dipropionate1 in 1 CARTONOINTMENT, AUGMENTED19
68180-947-02Betamethasone dipropionate50 g in 1 TUBEOINTMENT, AUGMENTED509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-947-01GM - Gram68180-947b65772da-027b-43a6-8e6e-77dad555a98312020-04-20
68180-947-02GM - Gram68180-947177bf9f1-daeb-425d-b9fd-85ca75687ac812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-947BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 4 package rows20250408_216d5b7f-4236-4882-b899-be17cb1a1584.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSN216d5b7f-4236-4882-b899-be17cb1a15849
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCD216d5b7f-4236-4882-b899-be17cb1a15849
848180augmented betamethasone 0.05 % Topical OintmentSY216d5b7f-4236-4882-b899-be17cb1a15849
848180betamethasone 0.05 % Augmented Topical OintmentSY216d5b7f-4236-4882-b899-be17cb1a15849
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSY216d5b7f-4236-4882-b899-be17cb1a15849
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSNb5291e39-40a0-4362-9281-97f5fb4025d93
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCDb5291e39-40a0-4362-9281-97f5fb4025d93
848180augmented betamethasone 0.05 % Topical OintmentSYb5291e39-40a0-4362-9281-97f5fb4025d93
848180betamethasone 0.05 % Augmented Topical OintmentSYb5291e39-40a0-4362-9281-97f5fb4025d93
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSYb5291e39-40a0-4362-9281-97f5fb4025d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-947-01681800947011 TUBE in 1 CARTON (68180-947-01) / 15 g in 1 TUBE1 tube2020-03-190000-00-00NoNoCurrent
68180-947-02681800947021 TUBE in 1 CARTON (68180-947-02) / 50 g in 1 TUBE1 tube2020-03-190000-00-00NoNoCurrent