Nucynta

Product NDC
55700-796
11-digit product format
557000796
Labeler code
55700
Product ID
55700-796_df84549d-352e-483f-b5f5-0e50e09c762e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tapentadol hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
NDA200533
Marketing category
NDA
Marketing start
2019-09-27
Marketing end
0000-00-00
Substance
TAPENTADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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
55700-796-60EA - Each55700-796311ffe0a-b2a5-467c-a9ab-19846054438612019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-796-605570007966060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-796-60) 2019-09-270000-00-00NoNoCurrent