Morphine sulfate

Product NDC
67296-1375
11-digit product format
672961375
Labeler code
67296
Product ID
67296-1375_d61b7098-31be-3b30-e053-2a95a90a2d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203849
Marketing category
ANDA
Marketing start
2015-10-26
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1375-22024-01-30C16284748780-11030e365-2922-111a-e063-dadaa90a10e2504a340d-2bf8-70b9-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1375-2Morphine sulfate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1375MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20220122_504a340d-2bf8-70b9-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891881morphine sulfate 15 MG Extended Release Oral TabletPSN504a340d-2bf8-70b9-e054-00144ff8d46c4
891881morphine sulfate 15 MG Extended Release Oral TabletSCD504a340d-2bf8-70b9-e054-00144ff8d46c4
891881MS 15 MG Extended Release Oral TabletSY504a340d-2bf8-70b9-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1375-26729613750220 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67296-1375-2) 2015-10-260000-00-00NoNoCurrent