FDA.reportPublic FDA data

Betamethasone Dipropionate

Product NDC
52565-019
11-digit product format
525650019
Labeler code
52565
Product ID
52565-019_0f582800-bd39-4e95-b38e-26f69729d505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA206118
Marketing category
ANDA
Marketing start
2017-10-30
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
52565-019-152023-01-30C16284748780-1f386c649-e560-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment. BETAMETHASONE DIPROPIONATE Ointment USP, (Augmented) 0.05% for topical use Initial U.S. Approval: 1983
52565-019-512023-01-30C16284748780-1f386c649-e560-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment. BETAMETHASONE DIPROPIONATE Ointment USP, (Augmented) 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-019-15Betamethasone Dipropionate1 in 1 CARTONOINTMENT15
52565-019-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT155
52565-019-51Betamethasone Dipropionate1 in 1 CARTONOINTMENT15
52565-019-51Betamethasone Dipropionate50 g in 1 TUBEOINTMENT505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-019-15GM - Gram52565-019414395c0-e2d2-4b06-9f9d-8d7a2331da0512018-07-03
52565-019-51GM - Gram52565-01969a6638c-63d1-4c52-8ff0-0c3b7e7528b512018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-019BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPIONATE) OINTMENT [TELIGENT PHARMA, INC.]5Legacy NDC, 4 package rows20191012_b1c3c530-6e28-4fba-9a9d-5fac9819e3e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSNb1c3c530-6e28-4fba-9a9d-5fac9819e3e65
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCDb1c3c530-6e28-4fba-9a9d-5fac9819e3e65
848180augmented betamethasone 0.05 % Topical OintmentSYb1c3c530-6e28-4fba-9a9d-5fac9819e3e65
848180betamethasone 0.05 % Augmented Topical OintmentSYb1c3c530-6e28-4fba-9a9d-5fac9819e3e65
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSYb1c3c530-6e28-4fba-9a9d-5fac9819e3e65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-019-15525650019151 TUBE in 1 CARTON (52565-019-15) > 15 g in 1 TUBE1 tube2017-10-300000-00-00NoNoCurrent
52565-019-51525650019511 TUBE in 1 CARTON (52565-019-51) > 50 g in 1 TUBE1 tube2017-10-300000-00-00NoNoCurrent