HALOG

Product NDC
10631-095
11-digit product format
106310095
Labeler code
10631
Product ID
10631-095_b2cf0aaa-872e-49bf-89f3-27b54469d4fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Halcinonide Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA017823
Marketing category
NDA
Marketing start
2020-03-18
Marketing end
0000-00-00
Substance
HALCINONIDE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10631-095-10ML - Milliliter10631-09596216792-92e4-4c3f-b5c3-87439136846712020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10631-095-10106310095101 BOTTLE, PLASTIC in 1 CARTON (10631-095-10) > 120 mL in 1 BOTTLE, PLASTIC2020-03-180000-00-00NoNoCurrent
10631-095-20106310095201 BOTTLE, PLASTIC in 1 CARTON (10631-095-20) > 60 mL in 1 BOTTLE, PLASTIC2020-03-180000-00-00NoNoCurrent
10631-095-98106310095984 BOTTLE, PLASTIC in 1 CARTON (10631-095-98) > 5 mL in 1 BOTTLE, PLASTIC (10631-095-06) 2020-03-180000-00-00YesNoCurrent