FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
63629-4484
11-digit product format
636294484
Labeler code
63629
Product ID
63629-4484_f76e4a94-1e80-4147-a689-c5b13661c7da
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
30 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891888

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
63629-4484-12020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-22020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-32020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-42020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-52020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-62020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-72020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-82020-10-12C16284748780-19d75b9d0-ee06-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
63629-4484-12020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-22020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-32020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-42020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-52020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-62020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-72020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-82020-01-31C16284748780-19d75b9d0-ee06-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
63629-4484-0Morphine Sulfate40 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE401012
63629-4484-1Morphine Sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301012
63629-4484-2Morphine Sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601012
63629-4484-3Morphine Sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901012
63629-4484-4Morphine Sulfate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201012
63629-4484-5Morphine Sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001012
63629-4484-6Morphine Sulfate5 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE51012
63629-4484-7Morphine Sulfate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE151012
63629-4484-8Morphine Sulfate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE201012
63629-4484-9Morphine Sulfate26 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE261012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4484-1EA - Each63629-4484cee03460-0076-4c1a-bd35-8515ac680eb712015-10-02
63629-4484-2EA - Each63629-4484d8ea9c5e-d47a-499f-bc2e-4a129a598f4a12015-10-02
63629-4484-3EA - Each63629-44848ea00261-35a0-4c85-ae01-5f99649edb2712012-07-24
63629-4484-4EA - Each63629-4484437d8f80-835d-4d72-87e4-501e2e429bd612013-02-13
63629-4484-5EA - Each63629-44844f1e2509-8b34-4948-a14c-b85eca4eae2312015-10-02
63629-4484-6EA - Each63629-4484e94a2324-4164-4980-9572-c3292b64ff6612015-10-02
63629-4484-7EA - Each63629-4484b5f5c428-68c0-4b75-9b20-f44f41db6a7f12025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4484MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 10 package rows20240524_cc3b491c-a206-3027-54f0-f87c0dd40a7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891888morphine sulfate 30 MG Extended Release Oral TabletPSNcc3b491c-a206-3027-54f0-f87c0dd40a7f1012
891888morphine sulfate 30 MG Extended Release Oral TabletSCDcc3b491c-a206-3027-54f0-f87c0dd40a7f1012
891888MS 30 MG Extended Release Oral TabletSYcc3b491c-a206-3027-54f0-f87c0dd40a7f1012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4484-06362944840040 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-0) 2021-12-220000-00-00NoNoCurrent
63629-4484-16362944840130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-1) 2011-04-180000-00-00NoNoCurrent
63629-4484-26362944840260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-2) 2011-04-180000-00-00NoNoCurrent
63629-4484-36362944840390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-3) 2011-05-030000-00-00NoNoCurrent
63629-4484-463629448404120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-4) 2012-05-070000-00-00NoNoCurrent
63629-4484-563629448405100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-5) 2011-08-250000-00-00NoNoCurrent
63629-4484-6636294484065 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-6) 2021-12-220000-00-00NoNoCurrent
63629-4484-76362944840715 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-7) 2014-04-290000-00-00NoNoCurrent
63629-4484-86362944840820 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-8) 2021-12-220000-00-00NoNoCurrent
63629-4484-96362944840926 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4484-9) 2021-12-220000-00-00NoNoCurrent