oxycodone and acetaminophen

Product NDC
57664-160
11-digit product format
576640160
Labeler code
57664
Product ID
57664-160_8df48502-9503-4e53-b637-23f035271bf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090535
Marketing category
ANDA
Marketing start
2015-11-02
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57664-160-882020-09-14C16284748780-1ab0e2407-2e17-f274-e053-dbdaa90a64715d7df029-54b5-419f-b0a4-2a1322a00718
57664-160-882020-07-22C16284748780-1ab0e2407-2e17-f274-e053-dbdaa90a64715d7df029-54b5-419f-b0a4-2a1322a00718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-160-88EA - Each57664-16098ffb2bb-8590-42b2-82e2-3cfa95fd5c9d12016-07-19