Oxycodone and Acetaminophen

Product NDC
55700-970
11-digit product format
557000970
Labeler code
55700
Product ID
55700-970_974604a8-869c-4275-81aa-7f31e00b1d12
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
2022-06-17
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
55700-970-01EA - Each55700-970e793885a-e0f0-4cd3-b692-3a538235cfb312022-07-06
55700-970-21EA - Each55700-9700ccf5952-e983-4fd2-a96d-474c51c23f7512022-07-06
55700-970-30EA - Each55700-970475f6940-d0c5-4bd3-a62c-9fc61243572a12022-07-06
55700-970-60EA - Each55700-970d9dbbf57-fa8a-4d7b-a660-09404a876da112022-07-06
55700-970-90EA - Each55700-970267ca43b-616b-478a-88dc-6a8c2f531ec112022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-970-0155700097001120 TABLET in 1 BOTTLE (55700-970-01) 120 tablet2022-06-170000-00-00NoNoCurrent
55700-970-215570009702121 TABLET in 1 BOTTLE (55700-970-21) 21 tablet2022-06-170000-00-00NoNoCurrent
55700-970-305570009703030 TABLET in 1 BOTTLE (55700-970-30) 30 tablet2022-06-170000-00-00NoNoCurrent
55700-970-605570009706060 TABLET in 1 BOTTLE (55700-970-60) 60 tablet2022-06-170000-00-00NoNoCurrent
55700-970-905570009709090 TABLET in 1 BOTTLE (55700-970-90) 90 tablet2022-06-170000-00-00NoNoCurrent