FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
52959-406
11-digit product format
529590406
Labeler code
52959
Product ID
52959-406_a0844f71-fb93-4a00-9908-dad2df9fdae7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA074862
Marketing category
ANDA
Marketing start
2011-01-14
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
2017-12-31
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
52959-406-022019-11-13C16284748780-197449f38-cf5c-f6ea-e053-dbdaa90aa703Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*
52959-406-302019-11-13C16284748780-197449f38-cf5c-f6ea-e053-dbdaa90aa703Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*
52959-406-602019-11-13C16284748780-197449f38-cf5c-f6ea-e053-dbdaa90aa703Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*
52959-406-902019-11-13C16284748780-197449f38-cf5c-f6ea-e053-dbdaa90aa703Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-406-02Morphine Sulfate120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1202
52959-406-30Morphine Sulfate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
52959-406-60Morphine Sulfate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
52959-406-90Morphine Sulfate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-406-02EA - Each52959-406a1b45dad-ae5d-4ca3-916d-13732ab5695012012-07-24
52959-406-30EA - Each52959-4063fde45a2-a05b-4139-8719-c5b46fe2ee1312012-07-24
52959-406-60EA - Each52959-4068b2919db-2ea3-4b6b-999e-7185f32d7a9112012-07-24
52959-406-90EA - Each52959-406edf45211-7ac0-45d2-8355-92400c4f3df912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-406MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 package rows20111214_73e60510-751a-419c-82bb-c958e61e495e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891881morphine sulfate 15 MG Extended Release Oral TabletPSN73e60510-751a-419c-82bb-c958e61e495e2
891888morphine sulfate 30 MG Extended Release Oral TabletPSN73e60510-751a-419c-82bb-c958e61e495e2
891881morphine sulfate 15 MG Extended Release Oral TabletSCD73e60510-751a-419c-82bb-c958e61e495e2
891888morphine sulfate 30 MG Extended Release Oral TabletSCD73e60510-751a-419c-82bb-c958e61e495e2
891881MS 15 MG Extended Release Oral TabletSY73e60510-751a-419c-82bb-c958e61e495e2
891888MS 30 MG Extended Release Oral TabletSY73e60510-751a-419c-82bb-c958e61e495e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-406-0252959040602120 in 1 BOTTLE, PLASTICHistorical
52959-406-305295904063030 in 1 BOTTLE, PLASTICHistorical
52959-406-605295904066060 in 1 BOTTLE, PLASTICHistorical
52959-406-905295904069090 in 1 BOTTLE, PLASTICHistorical