FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0054-0517
11-digit product format
000540517
Labeler code
0054
Product ID
0054-0517_1bfdbb7c-d06a-4010-82f9-189b59a2f18d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA022195
Marketing category
NDA
Marketing start
2008-03-17
Substance
MORPHINE SULFATE
Active strength
100 mg/5mL
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 SULFATE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892589, 892625, 894780

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
0054-0517-41Morphine Sulfate15 mL in 1 BOTTLESOLUTION154
0054-0517-44Morphine Sulfate30 mL in 1 BOTTLESOLUTION304
0054-0517-50Morphine Sulfate120 mL in 1 BOTTLESOLUTION1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0517-41ML - Milliliter0054-051710bc9b0f-a97b-4717-a999-1f5e7467013412015-09-10
0054-0517-44ML - Milliliter0054-05173bf8e136-330a-4f79-ac45-099f5ebe232712015-09-10
0054-0517-50ML - Milliliter0054-05179c5a2799-e66f-4698-aaf5-7ceb8246d1d112015-09-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0517MORPHINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 3 package rows20231223_ca359246-4674-4b32-b8b2-673d32b7112f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSNca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN67f0ee8d-696e-4c08-9007-3df0e3988bad4
894780morphine sulfate 20 MG in 5 mL Oral SolutionPSNca359246-4674-4b32-b8b2-673d32b7112f4
892589morphine sulfate 2 MG/ML Oral SolutionSCDca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG/ML Oral SolutionSCD839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 20 MG/ML Oral SolutionSCDca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG/ML Oral SolutionSCD67f0ee8d-696e-4c08-9007-3df0e3988bad4
894780morphine sulfate 4 MG/ML Oral SolutionSCDca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY67f0ee8d-696e-4c08-9007-3df0e3988bad4
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892589morphine sulfate 10 MG per 5 ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY67f0ee8d-696e-4c08-9007-3df0e3988bad4
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
894780morphine sulfate 20 MG per 5 ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY67f0ee8d-696e-4c08-9007-3df0e3988bad4
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892589MS 2 MG/ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625MS 20 MG/ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625MS 20 MG/ML Oral SolutionSY67f0ee8d-696e-4c08-9007-3df0e3988bad4
892625MS 20 MG/ML Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
894780MS 4 MG/ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNbb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN76966c05-df75-4072-ae99-97e42f91ab752
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN6605ced6-68fe-4d7d-baa6-2526f7c9a64a2
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN6654b91e-3b3f-4062-ac65-a2a70f942da42
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 20 MG/ML Oral SolutionSCDbb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2
892625morphine sulfate 20 MG/ML Oral SolutionSCD76966c05-df75-4072-ae99-97e42f91ab752
892625morphine sulfate 20 MG/ML Oral SolutionSCD6605ced6-68fe-4d7d-baa6-2526f7c9a64a2
892625morphine sulfate 20 MG/ML Oral SolutionSCD6654b91e-3b3f-4062-ac65-a2a70f942da42
892625morphine sulfate 20 MG/ML Oral SolutionSCDcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY6654b91e-3b3f-4062-ac65-a2a70f942da42
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYbb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY6605ced6-68fe-4d7d-baa6-2526f7c9a64a2
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY76966c05-df75-4072-ae99-97e42f91ab752
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY6605ced6-68fe-4d7d-baa6-2526f7c9a64a2
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYbb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY76966c05-df75-4072-ae99-97e42f91ab752
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY6654b91e-3b3f-4062-ac65-a2a70f942da42
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY6605ced6-68fe-4d7d-baa6-2526f7c9a64a2
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYbb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY76966c05-df75-4072-ae99-97e42f91ab752
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY6654b91e-3b3f-4062-ac65-a2a70f942da42
892625MS 20 MG/ML Oral SolutionSYbb6b3439-9f0c-45f5-bf6f-c7a971af0a8f2
892625MS 20 MG/ML Oral SolutionSY76966c05-df75-4072-ae99-97e42f91ab752
892625MS 20 MG/ML Oral SolutionSY6654b91e-3b3f-4062-ac65-a2a70f942da42
892625MS 20 MG/ML Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625MS 20 MG/ML Oral SolutionSY6605ced6-68fe-4d7d-baa6-2526f7c9a64a2
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNae57637e-a86a-4ea5-9c68-47d98153d41a1
892625morphine sulfate 20 MG/ML Oral SolutionSCDae57637e-a86a-4ea5-9c68-47d98153d41a1
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYae57637e-a86a-4ea5-9c68-47d98153d41a1
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYae57637e-a86a-4ea5-9c68-47d98153d41a1
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYae57637e-a86a-4ea5-9c68-47d98153d41a1
892625MS 20 MG/ML Oral SolutionSYae57637e-a86a-4ea5-9c68-47d98153d41a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0517-410005405174115 mL in 1 BOTTLE (0054-0517-41) 15 ml2015-08-100000-00-00NoNoCurrent
0054-0517-440005405174430 mL in 1 BOTTLE (0054-0517-44) 30 ml2015-08-100000-00-00NoNoCurrent
0054-0517-5000054051750120 mL in 1 BOTTLE (0054-0517-50) 120 ml2015-08-100000-00-00NoNoCurrent