FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
52959-182
11-digit product format
529590182
Labeler code
52959
Product ID
52959-182_3ac644a7-eb27-4023-b211-d9ed9c38c4e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA022195
Marketing category
NDA
Marketing start
2008-03-17
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
30 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
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
52959-182-022020-01-31C16284748780-19d75b9cf-d5b3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984
52959-182-302020-01-31C16284748780-19d75b9cf-d5b3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984
52959-182-602020-01-31C16284748780-19d75b9cf-d5b3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984
52959-182-902020-01-31C16284748780-19d75b9cf-d5b3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CII Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-182-02Morphine Sulfate120 in 1 BOTTLETABLET1202
52959-182-30Morphine Sulfate30 in 1 BOTTLETABLET302
52959-182-60Morphine Sulfate60 in 1 BOTTLETABLET602
52959-182-90Morphine Sulfate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-182-02EA - Each52959-1823a56c348-ec06-4108-83bb-7555c12af8b612012-07-24
52959-182-30EA - Each52959-182aa39b59c-7117-45be-8289-31189b5c0bcf12012-07-24
52959-182-60EA - Each52959-18270c1fc02-63ed-4f3d-91e7-8177eaf356e112012-07-24
52959-182-90EA - Each52959-1826ef8d841-cf37-4a5a-a8a7-b4c8d6278dad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.]2
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-182MORPHINE SULFATE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 package rows20111230_d4286d3c-7226-47a6-9fbc-e67e60e46286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892582morphine sulfate 15 MG Oral TabletPSNd4286d3c-7226-47a6-9fbc-e67e60e462862
892672morphine sulfate 30 MG Oral TabletPSNd4286d3c-7226-47a6-9fbc-e67e60e462862
892582morphine sulfate 15 MG Oral TabletSCDd4286d3c-7226-47a6-9fbc-e67e60e462862
892672morphine sulfate 30 MG Oral TabletSCDd4286d3c-7226-47a6-9fbc-e67e60e462862
892582MS 15 MG Oral TabletSYd4286d3c-7226-47a6-9fbc-e67e60e462862
892672MS 30 MG Oral TabletSYd4286d3c-7226-47a6-9fbc-e67e60e462862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-182-0252959018202120 in 1 BOTTLEHistorical
52959-182-305295901823030 in 1 BOTTLEHistorical
52959-182-605295901826060 in 1 BOTTLEHistorical
52959-182-905295901829090 in 1 BOTTLEHistorical