FDA.reportPublic FDA data

Halobetasol Propionate

Product NDC
52565-073
11-digit product format
525650073
Labeler code
52565
Product ID
52565-073_35da6f20-71cb-4679-8dca-bfd561b4c9fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209978
Marketing category
ANDA
Marketing start
2018-03-20
Marketing end
0000-00-00
Substance
HALOBETASOL PROPIONATE
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
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
9314f950-fe47-4276-b1f9-66d9d4a64eaeProduct name120220217
0bc08e12-b8ed-4802-abab-926d5509afb3Product name120210513
608e9379-3a63-4bf4-b035-b393ae8faa97Product name120190214
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3Product name120151123
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2Product name120140508
ee2f33ab-1561-3107-e994-434cb17b4d06Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-073-152023-01-30C16284748780-1f386c64a-1782-0266-e053-dadaa90a7c1aHalobetasol Propionate Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use. Rx only
52565-073-512023-01-30C16284748780-1f386c64a-1782-0266-e053-dadaa90a7c1aHalobetasol Propionate Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-073-15Halobetasol Propionate15 g in 1 TUBEOINTMENT152
52565-073-15Halobetasol Propionate1 in 1 CARTONOINTMENT12
52565-073-51Halobetasol Propionate50 g in 1 TUBEOINTMENT502
52565-073-51Halobetasol Propionate1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-073-15GM - Gram52565-073b1c3f6d3-f9bb-46a4-a9e1-0ddca78a84e412018-05-09
52565-073-51GM - Gram52565-073fe67d7a7-2d47-44ce-8208-28081297f11b12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-073HALOBETASOL PROPIONATE OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190911_102dd731-6f73-458f-9d95-9cdf14a5df06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSN102dd731-6f73-458f-9d95-9cdf14a5df062
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCD102dd731-6f73-458f-9d95-9cdf14a5df062
977978halobetasol propionate 0.05 % Topical OintmentSY102dd731-6f73-458f-9d95-9cdf14a5df062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-073-15525650073151 TUBE in 1 CARTON (52565-073-15) > 15 g in 1 TUBE1 tube2018-03-200000-00-00NoNoCurrent
52565-073-51525650073511 TUBE in 1 CARTON (52565-073-51) > 50 g in 1 TUBE1 tube2018-03-200000-00-00NoNoCurrent