Oxycodone and Acetaminophen

Product NDC
0527-1671
11-digit product format
005271671
Labeler code
0527
Product ID
0527-1671_280e762b-67ec-41a6-b1ef-1d99a09f787e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA207333
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
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
0527-1671-01EA - Each0527-1671c0a749bc-e911-4822-9597-69f1de87ce4512018-10-11
0527-1671-05EA - Each0527-1671499c4722-9965-471c-974a-4fe095b128df12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1671-0100527167101100 TABLET in 1 BOTTLE (0527-1671-01) 100 tablet2017-09-250000-00-00NoNoCurrent
0527-1671-0500527167105500 TABLET in 1 BOTTLE (0527-1671-05) 500 tablet2017-09-250000-00-00NoNoCurrent