FDA.reportPublic FDA data

Morphine sulfate

Product NDC
0228-4271
11-digit product format
002284271
Labeler code
0228
Product ID
0228-4271_7caa4c88-b5f3-410b-a824-87916d6c7655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA203849
Marketing category
ANDA
Marketing start
2015-10-26
Marketing end
2026-07-31
Substance
MORPHINE SULFATE
Active strength
30 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine sulfate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891874, 891881, 891888, 891893, 892646

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-4271-11Morphine sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-4271-11EA - Each0228-4271d221e6dc-2b73-4208-bf4f-b4f0d1286b8612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)INACTIVE INGREDIENT12VCE9HR9EMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-4271MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20240604_75fb4282-0bbd-4d63-a7d1-5142780a4fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881morphine sulfate 15 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
892646morphine sulfate 200 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891888morphine sulfate 30 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891893morphine sulfate 60 MG Extended Release Oral TabletPSN75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891874morphine sulfate 100 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881morphine sulfate 15 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
892646morphine sulfate 200 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891888morphine sulfate 30 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891893morphine sulfate 60 MG Extended Release Oral TabletSCD75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891874MS 100 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891881MS 15 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
892646MS 200 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891888MS 30 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20
891893MS 60 MG Extended Release Oral TabletSY75fb4282-0bbd-4d63-a7d1-5142780a4fae20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-4271-1100228427111100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4271-11) 2015-10-262026-07-31NoNoCurrent