KYNMOBI

Product NDC
63402-015
11-digit product format
634020015
Labeler code
63402
Product ID
63402-015_d6c3ecd5-c695-45b9-99c9-8e6a34488cca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apomorphine hydrochloride
Dosage form
FILM, SOLUBLE
Route
SUBLINGUAL
Labeler
Sunovion Pharmaceuticals Inc.
Application
NDA210875
Marketing category
NDA
Marketing start
2020-05-21
Marketing end
0000-00-00
Substance
APOMORPHINE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63402-015-01EA - Each63402-015b6297392-9043-46a5-a637-afed766d098d12020-07-13
63402-015-30EA - Each63402-015ca76e26b-927a-4f0a-81eb-10cc4e00bac012020-07-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63402-015-306340200153030 POUCH in 1 CARTON (63402-015-30) > 1 FILM, SOLUBLE in 1 POUCH (63402-015-01) 30 pouch2020-05-210000-00-00NoNoCurrent