FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
21695-614
11-digit product format
216950614
Labeler code
21695
Product ID
21695-614_389cdebb-55fe-4808-a5b7-0f293d9ee45d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rebel Distributors Corp.
Application
ANDA071012
Marketing category
ANDA
Marketing start
1987-02-03
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE
Active strength
0 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-614-452019-09-24C16284748780-1934fe258-4d7c-48b1-e053-8cdaa90a720aBETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% (potency expressed as betamethasone) For Dermatologic Use Only – Not for Ophthalmic Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-614-45Betamethasone Dipropionate1 in 1 CARTONOINTMENT11
21695-614-45Betamethasone Dipropionate45 g in 1 TUBEOINTMENT451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-614-45GM - Gram21695-6148237286f-b4d5-4107-9294-1aaa9c483d6512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betamethasone DipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1
BetamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-614BETAMETHASONE DIPROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100921_389cdebb-55fe-4808-a5b7-0f293d9ee45d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197405betamethasone dipropionate 0.05 % Topical OintmentPSN389cdebb-55fe-4808-a5b7-0f293d9ee45d1
197405betamethasone 0.0005 MG/MG Topical OintmentSCD389cdebb-55fe-4808-a5b7-0f293d9ee45d1
197405betamethasone 0.05 % Topical OintmentSY389cdebb-55fe-4808-a5b7-0f293d9ee45d1
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY389cdebb-55fe-4808-a5b7-0f293d9ee45d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-614-45216950614451 in 1 CARTONHistorical