Oxycodone and Acetaminophen

Product NDC
55700-497
11-digit product format
557000497
Labeler code
55700
Product ID
55700-497_8c9196fe-65e3-4e1f-b71b-ae9e08d5a4e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA201972
Marketing category
ANDA
Marketing start
2016-12-01
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
55700-497-01EA - Each55700-4972b92b9ae-69a5-4ced-b4de-0b2c79f2220a12017-03-06
55700-497-28EA - Each55700-497998186a5-a2f0-44e8-8a65-8c3c281fa65f12021-10-08
55700-497-30EA - Each55700-497dade9f9e-5d12-4fc6-9d22-e29d7009ec6712017-03-06
55700-497-60EA - Each55700-497e0f7ce7d-286d-4dff-b1f9-e0fe1c44784112017-03-06
55700-497-90EA - Each55700-4975c0bca15-204c-4783-b5f8-6fdf7bc2527512017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-497-0155700049701120 TABLET in 1 BOTTLE (55700-497-01) 120 tablet2017-02-100000-00-00NoNoCurrent
55700-497-285570004972828 TABLET in 1 BOTTLE (55700-497-28) 28 tablet2021-08-310000-00-00NoNoCurrent
55700-497-305570004973030 TABLET in 1 BOTTLE (55700-497-30) 30 tablet2017-02-100000-00-00NoNoCurrent
55700-497-605570004976060 TABLET in 1 BOTTLE (55700-497-60) 60 tablet2017-02-100000-00-00NoNoCurrent
55700-497-905570004979090 TABLET in 1 BOTTLE (55700-497-90) 90 tablet2017-02-100000-00-00NoNoCurrent