ZOHYDRO ER

Product NDC
65224-320
11-digit product format
652240320
Labeler code
65224
Product ID
65224-320_20d675b2-d568-4df4-8502-ccb156b9170e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Persion Pharmaceuticals LLC
Application
NDA202880
Marketing category
NDA
Marketing start
2013-10-25
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE
Active strength
20 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
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
65224-320-60EA - Each65224-3209702c4a1-ec59-47b0-a873-78e63e325ec212016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65224-320-606522403206060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65224-320-60) 2013-10-250000-00-00NoNoCurrent