FDA.reportPublic FDA data

betamethasone dipropionate

Product NDC
52565-023
11-digit product format
525650023
Labeler code
52565
Product ID
52565-023_3e7bbd47-5cf6-4aac-9653-271bf6e4d584
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone dipropionate
Dosage form
LOTION, AUGMENTED
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA206389
Marketing category
ANDA
Marketing start
2018-02-14
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE
Active strength
1 mg/mL
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-023-292023-01-30C16284748780-1f386c64a-0022-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion safely and effectively. See full prescribing information for BETHAMETHASONE DIPROPIONATE Lotion. BETAMETHASONE DIPROPIONATE Lotion, USP (Augmented) 0.05% for topical use Initial U.S. Approval: 1983
52565-023-592023-01-30C16284748780-1f386c64a-0022-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion safely and effectively. See full prescribing information for BETHAMETHASONE DIPROPIONATE Lotion. BETAMETHASONE DIPROPIONATE Lotion, USP (Augmented) 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-023-29betamethasone dipropionate1 in 1 CARTONLOTION, AUGMENTED14
52565-023-29betamethasone dipropionate30 mL in 1 BOTTLE, PLASTICLOTION, AUGMENTED304
52565-023-59betamethasone dipropionate1 in 1 CARTONLOTION, AUGMENTED14
52565-023-59betamethasone dipropionate60 mL in 1 BOTTLE, PLASTICLOTION, AUGMENTED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-023-29ML - Milliliter52565-023c52edb9b-5324-4840-a03f-1ce14a76c44d12018-05-09
52565-023-59ML - Milliliter52565-023a084ee85-1910-4abf-9317-19ead404aedf12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-023BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TELIGENT PHARMA, INC.]4Legacy NDC, 4 package rows20191012_3b4b9e5a-769d-7034-c381-6796837a2e24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionPSN3b4b9e5a-769d-7034-c381-6796837a2e244
848178Augmented betamethasone 0.5 MG/ML Topical LotionSCD3b4b9e5a-769d-7034-c381-6796837a2e244
848178augmented betamethasone 0.05 % Topical LotionSY3b4b9e5a-769d-7034-c381-6796837a2e244
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionSY3b4b9e5a-769d-7034-c381-6796837a2e244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52565-023-29525650023291 BOTTLE, PLASTIC in 1 CARTON (52565-023-29) > 30 mL in 1 BOTTLE, PLASTIC2018-02-140000-00-00NoNoCurrent
52565-023-59525650023591 BOTTLE, PLASTIC in 1 CARTON (52565-023-59) > 60 mL in 1 BOTTLE, PLASTIC2018-02-140000-00-00NoNoCurrent