Oxycodone and Acetaminophen

Product NDC
35356-802
11-digit product format
353560802
Labeler code
35356
Product ID
35356-802_428059f2-0361-4b6b-8082-bf627053a9a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Product s LLC
Application
ANDA202677
Marketing category
ANDA
Marketing start
2012-08-02
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-802-01EA - Each35356-8025c11d8ee-525c-44e4-a54b-cffcedeba92c12013-02-19
35356-802-15EA - Each35356-802283e0420-538d-45f1-8da7-e9236302bd9812016-10-06
35356-802-30EA - Each35356-802f96895e8-8ee7-4438-be12-c723ef2bdd7c12013-02-19
35356-802-40EA - Each35356-80203fdd5e0-1d6f-4bf3-a1e0-b1de09b1d32112013-02-19
35356-802-60EA - Each35356-8026691e7a4-f54a-431e-9235-dd67cfd06b7712013-02-19
35356-802-90EA - Each35356-802d043a51d-c44e-48f5-a385-869f03a0a5a012013-02-19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-802OXYCODONE AND ACETAMINOPHEN TABLET [QUALITY CARE PRODUCTS, LLC]7Legacy NDC20241219_bbbc5dc1-5a91-4430-adcb-a5f6963cc0a2.zip