FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
40032-544
11-digit product format
400320544
Labeler code
40032
Product ID
40032-544_45a60fd8-71d8-4bf4-9946-372f7b39b2b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA203602
Marketing category
ANDA
Marketing start
2015-12-16
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
200 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-544-012025-01-30C16284748780-12cef2736-65b1-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MORPHINE SULFATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE EXTENDED-RELEASE TABLETS. MORPHINE SULFATE extended-release tablets, for oral use CII Initial U.S. Approval: 1941
40032-544-052025-01-30C16284748780-12cef2736-65b1-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MORPHINE SULFATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE EXTENDED-RELEASE TABLETS. MORPHINE SULFATE extended-release tablets, for oral use CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-544-01Morphine Sulfate100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
40032-544-05Morphine Sulfate500 in 1 BOTTLETABLET, EXTENDED RELEASE5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-544MORPHINE SULFATE TABLET, EXTENDED RELEASE [NOVEL LABORATORIES, INC.]6Legacy NDC, 2 package rows20191222_e044604d-f210-4411-a6e8-6a9dbdb1a9bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891881morphine sulfate 15 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
892646morphine sulfate 200 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891888morphine sulfate 30 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891893morphine sulfate 60 MG Extended Release Oral TabletPSNe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891874morphine sulfate 100 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891881morphine sulfate 15 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
892646morphine sulfate 200 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891888morphine sulfate 30 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891893morphine sulfate 60 MG Extended Release Oral TabletSCDe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891874MS 100 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891881MS 15 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
892646MS 200 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891888MS 30 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6
891893MS 60 MG Extended Release Oral TabletSYe044604d-f210-4411-a6e8-6a9dbdb1a9bd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
40032-544-0140032054401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-544-01) 2015-12-160000-00-00NoNoCurrent
40032-544-0540032054405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-544-05) 2015-12-160000-00-00NoNoCurrent