Morphine Sulfate

Product NDC
51862-188
11-digit product format
518620188
Labeler code
51862
Product ID
51862-188_d65d4561-fca0-4ac9-9406-119c00607bf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA205386
Marketing category
ANDA
Marketing start
2016-11-01
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51862-188-012026-01-26C16284748780-12cef2736-7dc0-d83d-e063-dadaa90ab31f053e3fd9-25fc-4b55-b683-63fb9d190dae
51862-188-012025-01-30C16284748780-12cef2736-7dc0-d83d-e063-dadaa90ab31f053e3fd9-25fc-4b55-b683-63fb9d190dae

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-188MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAYNE PHARMA COMMERCIAL LLC]8Legacy NDC20230707_053e3fd9-25fc-4b55-b683-63fb9d190dae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51862-188-0151862018801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-188-01) 2016-11-010000-00-00NoNoCurrent