FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
42858-803
11-digit product format
428580803
Labeler code
42858
Product ID
42858-803_ccb2d4f4-3f19-40cd-9653-cec37213f8a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
ANDA074862
Marketing category
ANDA
Marketing start
2011-01-14
Substance
MORPHINE SULFATE
Active strength
60 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine Sulfate
Brand name suffix
Extended Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE60 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42858-803-01Morphine SulfateExtended Release100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-803-01EA - Each42858-8037214ba5c-2fe9-4c7e-9494-89d5f79dafaa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-803MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]13Current NDC, Legacy NDC, 1 package rows20240120_19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891881morphine sulfate 15 MG Extended Release Oral TabletPSN19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
892646morphine sulfate 200 MG Extended Release Oral TabletPSN19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891888morphine sulfate 30 MG Extended Release Oral TabletPSN19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891893morphine sulfate 60 MG Extended Release Oral TabletPSN19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891874morphine sulfate 100 MG Extended Release Oral TabletSCD19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891881morphine sulfate 15 MG Extended Release Oral TabletSCD19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
892646morphine sulfate 200 MG Extended Release Oral TabletSCD19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891888morphine sulfate 30 MG Extended Release Oral TabletSCD19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891893morphine sulfate 60 MG Extended Release Oral TabletSCD19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891874MS 100 MG Extended Release Oral TabletSY19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891881MS 15 MG Extended Release Oral TabletSY19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
892646MS 200 MG Extended Release Oral TabletSY19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891888MS 30 MG Extended Release Oral TabletSY19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891893MS 60 MG Extended Release Oral TabletSY19c7d9cc-6ce2-4c5c-8c3f-c24fd334280416
891874morphine sulfate 100 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891881morphine sulfate 15 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891888morphine sulfate 30 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891893morphine sulfate 60 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891874morphine sulfate 100 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891881morphine sulfate 15 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891888morphine sulfate 30 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891893morphine sulfate 60 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891874MS 100 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891881MS 15 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891888MS 30 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891893MS 60 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42858-803-0142858080301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-803-01) 2011-01-140000-00-00NoNoCurrent