FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0054-0238
11-digit product format
000540238
Labeler code
0054
Product ID
0054-0238_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
20 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 SULFATE20 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0238-49Morphine Sulfate100 mL in 1 BOTTLESOLUTION1004
0054-0238-63Morphine Sulfate500 mL in 1 BOTTLESOLUTION5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0238-49ML - Milliliter0054-02384ce76ead-6101-4f79-8615-798a73979a3c12012-07-24
0054-0238-63ML - Milliliter0054-023863a84042-2022-4505-9993-b4d89acf299b12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0238MORPHINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20231223_ca359246-4674-4b32-b8b2-673d32b7112f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
894780morphine sulfate 20 MG in 5 mL Oral SolutionPSN3c6a7216-e49b-411c-b53a-dd952ecfa0396
894780morphine sulfate 4 MG/ML Oral SolutionSCD3c6a7216-e49b-411c-b53a-dd952ecfa0396
894780morphine sulfate 20 MG per 5 ML Oral SolutionSY3c6a7216-e49b-411c-b53a-dd952ecfa0396
894780MS 4 MG/ML Oral SolutionSY3c6a7216-e49b-411c-b53a-dd952ecfa0396
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
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 SolutionSCDca359246-4674-4b32-b8b2-673d32b7112f4
894780morphine sulfate 4 MG/ML Oral SolutionSCDca359246-4674-4b32-b8b2-673d32b7112f4
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 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
892589MS 2 MG/ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
892625MS 20 MG/ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4
894780MS 4 MG/ML Oral SolutionSYca359246-4674-4b32-b8b2-673d32b7112f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0238-4900054023849100 mL in 1 BOTTLE (0054-0238-49) 100 ml2008-03-170000-00-00NoNoCurrent
0054-0238-6300054023863500 mL in 1 BOTTLE (0054-0238-63) 500 ml2008-03-170000-00-00NoNoCurrent