Oxycodone and Acetaminophen

Product NDC
55700-967
11-digit product format
557000967
Labeler code
55700
Product ID
55700-967_c73c6ec0-1c43-44ac-bfa6-3609e429fea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA207419
Marketing category
ANDA
Marketing start
2022-05-03
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-967-28EA - Each55700-967715c7a61-79c5-43ed-b7a2-1c53231fc59312022-07-06
55700-967-60EA - Each55700-96717f7414d-212c-413b-a3f8-e459e54ddbc412022-09-12
55700-967-90EA - Each55700-967060fa915-4444-4e42-93b9-5c6ec8f2d7f712022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-967-285570009672828 TABLET in 1 BOTTLE (55700-967-28) 28 tablet2022-05-130000-00-00NoNoCurrent
55700-967-605570009676060 TABLET in 1 BOTTLE (55700-967-60) 60 tablet2022-08-040000-00-00NoNoCurrent
55700-967-905570009679090 TABLET in 1 BOTTLE (55700-967-90) 90 tablet2022-05-030000-00-00NoNoCurrent