Hydrocodone Bitartrate

Product NDC
65224-950
11-digit product format
652240950
Labeler code
65224
Product ID
65224-950_33bacd82-e63c-4d97-af99-67f7ca782e6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Persion Pharmaceuticals LLC
Application
NDA202880
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-10-25
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE
Active strength
50 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
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
65224-950-60EA - Each65224-9507ce12494-76f6-4c3f-8211-63031e79b7be12020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65224-950-606522409506060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65224-950-60) 2013-10-250000-00-00NoNoCurrent