FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
66993-897
11-digit product format
669930897
Labeler code
66993
Product ID
66993-897_12719a3b-0bf5-4d12-8562-1c3799d5391c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA018741
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-06-01
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
66993-897-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT1512
66993-897-15Betamethasone Dipropionate1 in 1 BOXOINTMENT112
66993-897-49Betamethasone Dipropionate50 g in 1 TUBEOINTMENT5012
66993-897-49Betamethasone Dipropionate1 in 1 BOXOINTMENT112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-897-15GM - Gram66993-897daabe5a0-3f1a-4ede-b8b7-d8d2318055ca12013-02-13
66993-897-49GM - Gram66993-897d7d9e3ff-42c8-41aa-ba99-22d36f02446a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]3
betamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3BETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]3
propylene glycol monopalmitostearateINACTIVE INGREDIENTF76354LMGRBETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]3
white waxINACTIVE INGREDIENT7G1J5DA97FBETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-897BETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES]11Current NDC, Legacy NDC, 4 package rows20231110_f5b50c00-cc6f-4296-a9ae-b16888cef4dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSNf5b50c00-cc6f-4296-a9ae-b16888cef4dd12
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCDf5b50c00-cc6f-4296-a9ae-b16888cef4dd12
848180augmented betamethasone 0.05 % Topical OintmentSYf5b50c00-cc6f-4296-a9ae-b16888cef4dd12
848180betamethasone 0.05 % Augmented Topical OintmentSYf5b50c00-cc6f-4296-a9ae-b16888cef4dd12
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSYf5b50c00-cc6f-4296-a9ae-b16888cef4dd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-897-15669930897151 TUBE in 1 BOX (66993-897-15) / 15 g in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent
66993-897-49669930897491 TUBE in 1 BOX (66993-897-49) / 50 g in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent