FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0574-7110
11-digit product format
005747110
Labeler code
0574
Product ID
0574-7110_fa18ac09-a625-47aa-8cde-7051dc4d0c49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Padagis US LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1990-09-01
Substance
MORPHINE SULFATE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892516, 892603, 892678, 894807

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
0574-7110-12Morphine Sulfate12 in 1 BOXSUPPOSITORY127
0574-7110-12Morphine Sulfate1 in 1 PACKETSUPPOSITORY17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7110-12EA - Each0574-711026806f05-af97-4401-ac00-e85db824d10812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KMORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE SUPPOSITORY [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7110MORPHINE SULFATE SUPPOSITORY [PADAGIS US LLC]7Current NDC, Legacy NDC, 2 package rows20240627_649d731b-962a-45df-b043-7e0781e8a530.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
894807morphine sulfate 5 MG Rectal SuppositoryPSNf4f9a7cd-fa6c-41cd-8c4b-04626cfa410a103
894807morphine sulfate 5 MG Rectal SuppositorySCDf4f9a7cd-fa6c-41cd-8c4b-04626cfa410a103
894807MS 5 MG Rectal SuppositorySYf4f9a7cd-fa6c-41cd-8c4b-04626cfa410a103
892516morphine sulfate 10 MG Rectal SuppositoryPSN649d731b-962a-45df-b043-7e0781e8a5307
892603morphine sulfate 20 MG Rectal SuppositoryPSN649d731b-962a-45df-b043-7e0781e8a5307
892678morphine sulfate 30 MG Rectal SuppositoryPSN649d731b-962a-45df-b043-7e0781e8a5307
894807morphine sulfate 5 MG Rectal SuppositoryPSN649d731b-962a-45df-b043-7e0781e8a5307
892516morphine sulfate 10 MG Rectal SuppositorySCD649d731b-962a-45df-b043-7e0781e8a5307
892603morphine sulfate 20 MG Rectal SuppositorySCD649d731b-962a-45df-b043-7e0781e8a5307
892678morphine sulfate 30 MG Rectal SuppositorySCD649d731b-962a-45df-b043-7e0781e8a5307
894807morphine sulfate 5 MG Rectal SuppositorySCD649d731b-962a-45df-b043-7e0781e8a5307
892516MS 10 MG Rectal SuppositorySY649d731b-962a-45df-b043-7e0781e8a5307
892603MS 20 MG Rectal SuppositorySY649d731b-962a-45df-b043-7e0781e8a5307
892678MS 30 MG Rectal SuppositorySY649d731b-962a-45df-b043-7e0781e8a5307
894807MS 5 MG Rectal SuppositorySY649d731b-962a-45df-b043-7e0781e8a5307

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-7110-120057471101212 PACKET in 1 BOX (0574-7110-12) / 1 SUPPOSITORY in 1 PACKET12 packet1990-09-010000-00-00NoNoCurrent