OXYCODONE AND ACETAMINOPHEN

Product NDC
55700-984
11-digit product format
557000984
Labeler code
55700
Product ID
55700-984_75d2dedc-4b3a-41f9-8aaf-cdbfce5c4db8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA040545
Marketing category
ANDA
Marketing start
2022-09-28
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
55700-984-30EA - Each55700-984e286c9c4-1f86-4470-b6a5-f8ef14578f8b12022-10-06
55700-984-60EA - Each55700-984fb4cbc5c-dde1-4f02-b3bb-956556cb20d012022-10-06
55700-984-90EA - Each55700-984b5072f7b-8130-43ec-be20-3f6a9355a84312022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-984OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [QUALITY CARE PRODUCTS, LLC]3Legacy NDC20241225_c33734a7-2abb-47f3-abeb-041a2c033225.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-984-305570009843030 TABLET in 1 BOTTLE (55700-984-30) 30 tablet2022-09-280000-00-00NoNoCurrent
55700-984-605570009846060 TABLET in 1 BOTTLE (55700-984-60) 60 tablet2022-09-280000-00-00NoNoCurrent
55700-984-905570009849090 TABLET in 1 BOTTLE (55700-984-90) 90 tablet2022-09-280000-00-00NoNoCurrent