FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
63629-4483
11-digit product format
636294483
Labeler code
63629
Product ID
63629-4483_a6e982b8-e597-4955-9387-b1404883682b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074862
Marketing category
ANDA
Marketing start
2011-01-14
Substance
MORPHINE SULFATE
Active strength
15 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
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891881

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
63629-4483-02022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-12022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-22022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-32022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-42022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-52022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-62022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-72022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-82022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-92022-01-03C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-02020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-12020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-22020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-32020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-42020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-52020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-62020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-72020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-82020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-92020-01-31C16284748780-19d75b9d0-25f0-f424-e053-dadaa90a57ceThese 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
63629-4483-0Morphine SulfateER26 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE261017
63629-4483-1Morphine SulfateER30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301017
63629-4483-2Morphine SulfateER60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601017
63629-4483-3Morphine SulfateER90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901017
63629-4483-4Morphine SulfateER120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201017
63629-4483-5Morphine SulfateER40 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE401017
63629-4483-6Morphine SulfateER14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE141017
63629-4483-7Morphine SulfateER15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE151017
63629-4483-8Morphine SulfateER20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE201017
63629-4483-9Morphine SulfateER84 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE841017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4483-1EA - Each63629-44838a788c68-ffb6-4934-bc1a-f5dbe7c251d512012-07-24
63629-4483-2EA - Each63629-4483ca615cf5-708e-4bd0-b8ad-a8ac11d0bf0712012-07-24
63629-4483-3EA - Each63629-4483bebc71a1-452d-4606-b6fa-bb571d38645512012-07-24
63629-4483-4EA - Each63629-44833cb0deef-7253-49e4-ac38-7c70fb1b16a112013-02-13
63629-4483-5EA - Each63629-4483a2056a05-38ad-490a-b6ed-02a06eee79ea12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4483MORPHINE SULFATE ER (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1016Current NDC, Legacy NDC, 10 package rows20240524_872ceecb-1f14-7a43-7451-e4650a01fbd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891881morphine sulfate 15 MG Extended Release Oral TabletPSN872ceecb-1f14-7a43-7451-e4650a01fbd91017
891881morphine sulfate 15 MG Extended Release Oral TabletSCD872ceecb-1f14-7a43-7451-e4650a01fbd91017
891881MS 15 MG Extended Release Oral TabletSY872ceecb-1f14-7a43-7451-e4650a01fbd91017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4483-06362944830026 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-0) 2022-01-030000-00-00NoNoCurrent
63629-4483-16362944830130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-1) 2011-04-200000-00-00NoNoCurrent
63629-4483-26362944830260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-2) 2011-04-140000-00-00NoNoCurrent
63629-4483-36362944830390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-3) 2011-07-110000-00-00NoNoCurrent
63629-4483-463629448304120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-4) 2022-01-030000-00-00NoNoCurrent
63629-4483-56362944830540 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-5) 2022-01-030000-00-00NoNoCurrent
63629-4483-66362944830614 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-6) 2012-08-130000-00-00NoNoCurrent
63629-4483-76362944830715 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-7) 2014-04-290000-00-00NoNoCurrent
63629-4483-86362944830820 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-8) 2022-01-030000-00-00NoNoCurrent
63629-4483-96362944830984 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-9) 2015-04-150000-00-00NoNoCurrent