Oxycodone and Acetaminophen

Product NDC
35356-801
11-digit product format
353560801
Labeler code
35356
Product ID
35356-801_f71642ee-fb46-43a0-aa5f-a7ceddb5a5a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA202677
Marketing category
ANDA
Marketing start
2012-08-02
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
35356-801-01EA - Each35356-80195c3fd82-a297-4bf5-91ab-6f3fe2d93a6512013-02-19
35356-801-30EA - Each35356-801fd408a91-0e42-4c24-881d-0e4d66d8f6c912013-02-19
35356-801-60EA - Each35356-80182396b50-bd97-4856-b041-cae0c675321a12013-02-19
35356-801-90EA - Each35356-80105676c1a-4d5c-46f9-b142-373cae8be64612013-02-19

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-801OXYCODONE AND ACETAMINOPHEN TABLET [QUALITY CARE PRODUCTS, LLC]7Legacy NDC20241219_bbbc5dc1-5a91-4430-adcb-a5f6963cc0a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-801-303535608013030 TABLET in 1 BOTTLE (35356-801-30) 30 tablet2013-09-100000-00-00NoNoCurrent
35356-801-603535608016060 TABLET in 1 BOTTLE (35356-801-60) 60 tablet2013-09-100000-00-00NoNoCurrent
35356-801-903535608019090 TABLET in 1 BOTTLE (35356-801-90) 90 tablet2013-09-100000-00-00NoNoCurrent