FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0574-7116
11-digit product format
005747116
Labeler code
0574
Product ID
0574-7116_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
30 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 SULFATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X3P646A2J0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
892516Internal RxNorm lookup
892603Internal RxNorm lookup
892678Internal RxNorm lookup
894807Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
649d731b-962a-45df-b043-7e0781e8a530Available on FDA.report

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
0574-7116-12Morphine Sulfate12 in 1 BOXSUPPOSITORY127
0574-7116-12Morphine Sulfate1 in 1 PACKETSUPPOSITORY17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7116-12EA - Each0574-71165ea8963d-1a95-48f1-9f0d-25282226d66912013-02-13

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
0574-7116MORPHINE SULFATE SUPPOSITORY [PADAGIS US LLC]7Current NDC, Legacy NDC, 2 package rows20240627_649d731b-962a-45df-b043-7e0781e8a530.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morphine SulfateMORPHINE SULFATEPadagis US LLC649d731b-962a-45df-b043-7e0781e8a5302023-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0574-7116

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892678morphine sulfate 30 MG Rectal SuppositoryPSN996ac31e-589f-4d5a-84bc-8350e7ea864f103
892678morphine sulfate 30 MG Rectal SuppositorySCD996ac31e-589f-4d5a-84bc-8350e7ea864f103
892678MS 30 MG Rectal SuppositorySY996ac31e-589f-4d5a-84bc-8350e7ea864f103
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
0574-7116-120057471161212 PACKET in 1 BOX (0574-7116-12) / 1 SUPPOSITORY in 1 PACKET12 packet1990-09-010000-00-00NoNoCurrent