Oxycodone and Acetaminophen

Product NDC
63629-7825
11-digit product format
636297825
Labeler code
63629
Product ID
63629-7825_5e5c9284-293f-40a1-a622-bc564124274a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7825-12020-10-12C16284748780-19d75b9cf-f0f2-f424-e053-dadaa90a57ce9f63d35b-6a38-43d4-b025-6e5f30eba73d
63629-7825-12020-01-31C16284748780-19d75b9cf-f0f2-f424-e053-dadaa90a57ce9f63d35b-6a38-43d4-b025-6e5f30eba73d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7825-1EA - Each63629-782585d9afc5-e79a-4d4a-aa3d-66795c4f79d212019-01-24