Ultravate

Product NDC
10631-122
11-digit product format
106310122
Labeler code
10631
Product ID
10631-122_8afe3d44-b60c-4ba2-ab6c-8da871fc62b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
halobetasol propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA208183
Marketing category
NDA
Marketing start
2016-03-01
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-122-04ML - Milliliter10631-1224d4b2c71-68e7-439f-a2f8-01b9263fa8b712016-05-16
10631-122-51ML - Milliliter10631-122cdadacab-0511-42cb-88ad-e24bdc470e9112018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10631-122-041063101220459 g in 1 BOTTLE (10631-122-04) 59 g2016-03-010000-00-00NoNoCurrent
10631-122-51106310122512 BOTTLE in 1 CARTON (10631-122-51) > 59 g in 1 BOTTLE (10631-122-04) 2 bottle2018-03-190000-00-00NoNoCurrent
10631-122-70106310122705 TUBE in 1 CARTON (10631-122-70) > 2 g in 1 TUBE (10631-122-19) 5 tube2016-04-160000-00-00NoNoCurrent