morphine sulfate

Product NDC
35356-836
11-digit product format
353560836
Labeler code
35356
Product ID
35356-836_f406500a-5850-462b-a7b0-30ca11a48792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA074862
Marketing category
ANDA
Marketing start
2011-01-14
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
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
35356-836-01EA - Each35356-83632b60bb1-cd79-4af0-b8a3-ed2a3f74311b12013-04-01
35356-836-30EA - Each35356-836ca5f0dd0-e6fc-4377-b0a2-b2447b212a3d12013-04-01
35356-836-60EA - Each35356-836d18f902e-ce57-4b5f-8fec-98c594bf7a4812013-04-01
35356-836-90EA - Each35356-8365965342d-448c-432a-8b5c-cce8f0937f1912013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35356-836-0135356083601120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-836-01) 2011-01-140000-00-00NoNoCurrent
35356-836-603535608366060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-836-60) 2011-01-140000-00-00NoNoCurrent