Levorphanol Tartrate

Product NDC
42358-103
11-digit product format
423580103
Labeler code
42358
Product ID
42358-103_4462b208-8ef1-49dc-a55a-bdc6d0df8951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levorphanol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Sentynl Therapeutics, Inc.
Application
ANDA074278
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
2023-02-28
Substance
LEVORPHANOL TARTRATE
Active strength
3 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42358-103-10EA - Each42358-103843220f6-d754-43b9-88a2-89ad2312345412019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42358-103-1042358010310100 TABLET in 1 BOTTLE, PLASTIC (42358-103-10) 100 tablet2018-06-182023-02-28NoNoCurrent