FDA.reportPublic FDA data

Halobetasol Propionate

Product NDC
70752-119
11-digit product format
707520119
Labeler code
70752
Product ID
70752-119_a0847638-e772-4074-a2b5-8069589cff02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA213560
Marketing category
ANDA
Marketing start
2020-10-06
Substance
HALOBETASOL PROPIONATE
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
Halobetasol Propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOBETASOL PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii91A0K1TY3Z
Rxcui977978

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
70752-119-022023-02-02C16284748780-1f386c649-a68d-0266-e053-dadaa90a7c1aHalobetasol Propionate Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use.
70752-119-042023-02-02C16284748780-1f386c649-a68d-0266-e053-dadaa90a7c1aHalobetasol Propionate Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use.
70752-119-022023-01-30C16284748780-1f386c649-a68d-0266-e053-dadaa90a7c1aHalobetasol Propionate Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use.
70752-119-042023-01-30C16284748780-1f386c649-a68d-0266-e053-dadaa90a7c1aHalobetasol Propionate Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-119-02Halobetasol Propionate1 in 1 CARTONOINTMENT12
70752-119-02Halobetasol Propionate15 g in 1 TUBEOINTMENT152
70752-119-04Halobetasol Propionate50 g in 1 TUBEOINTMENT502
70752-119-04Halobetasol Propionate1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-119-02GM - Gram70752-1198d9cb4c3-fe1f-498f-b848-171dba2d0a5012021-02-05
70752-119-04GM - Gram70752-119e35d02a2-730d-4d13-ba80-3e149cbc520412021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-119HALOBETASOL PROPIONATE OINTMENT [QUAGEN PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 4 package rows20230203_fd4ebec1-e5ba-46cc-9627-4645a7b3bf19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977978halobetasol propionate 0.05 % Topical OintmentPSNc4e78fa5-6ced-4c90-89c6-31e5fc71b837103
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCDc4e78fa5-6ced-4c90-89c6-31e5fc71b837103
977978halobetasol propionate 0.05 % Topical OintmentSYc4e78fa5-6ced-4c90-89c6-31e5fc71b837103
977978halobetasol propionate 0.05 % Topical OintmentPSNfd4ebec1-e5ba-46cc-9627-4645a7b3bf192
977978halobetasol propionate 0.0005 MG/MG Topical OintmentSCDfd4ebec1-e5ba-46cc-9627-4645a7b3bf192
977978halobetasol propionate 0.05 % Topical OintmentSYfd4ebec1-e5ba-46cc-9627-4645a7b3bf192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-119-02707520119021 TUBE in 1 CARTON (70752-119-02) / 15 g in 1 TUBE1 tube2020-10-060000-00-00NoNoCurrent
70752-119-04707520119041 TUBE in 1 CARTON (70752-119-04) / 50 g in 1 TUBE1 tube2020-10-060000-00-00NoNoCurrent