FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0054-0237
11-digit product format
000540237
Labeler code
0054
Product ID
0054-0237_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
10 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 SULFATE10 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
0054-0237-41Morphine Sulfate15 mL in 1 BOTTLESOLUTION154
0054-0237-49Morphine Sulfate100 mL in 1 BOTTLESOLUTION1004
0054-0237-55Morphine Sulfate5 mL in 1 CUP, UNIT-DOSESOLUTION54
0054-0237-55Morphine Sulfate10 in 1 BOXSOLUTION104
0054-0237-63Morphine Sulfate500 mL in 1 BOTTLESOLUTION5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0237-41ML - Milliliter0054-0237c22cc989-f018-4a66-8075-bc2fcd92017212014-10-03
0054-0237-49ML - Milliliter0054-02376ddaa303-f101-4fab-9e88-2b1de8a32d6012012-07-24
0054-0237-55ML - Milliliter0054-023769efc702-9e5e-4518-9587-66521467afc012012-07-24
0054-0237-63ML - Milliliter0054-02376744e424-d866-41db-afc2-2bf8bb201ac212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0237MORPHINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 5 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 SolutionPSN6e32b869-31c7-48c1-98ae-b21bd28151d710
892589morphine sulfate 2 MG/ML Oral SolutionSCD6e32b869-31c7-48c1-98ae-b21bd28151d710
892589morphine sulfate 10 MG per 5 ML Oral SolutionSY6e32b869-31c7-48c1-98ae-b21bd28151d710
892589MS 2 MG/ML Oral SolutionSY6e32b869-31c7-48c1-98ae-b21bd28151d710
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSN8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589morphine sulfate 2 MG/ML Oral SolutionSCD8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589morphine sulfate 10 MG per 5 ML Oral SolutionSY8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589MS 2 MG/ML Oral SolutionSY8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSN12c17cfb-7bcf-4457-b1b9-531d7562493c7
892589morphine sulfate 2 MG/ML Oral SolutionSCD12c17cfb-7bcf-4457-b1b9-531d7562493c7
892589morphine sulfate 10 MG per 5 ML Oral SolutionSY12c17cfb-7bcf-4457-b1b9-531d7562493c7
892589MS 2 MG/ML Oral SolutionSY12c17cfb-7bcf-4457-b1b9-531d7562493c7
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
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSN9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb2
892589morphine sulfate 2 MG/ML Oral SolutionSCD9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb2
892589morphine sulfate 10 MG per 5 ML Oral SolutionSY9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb2
892589MS 2 MG/ML Oral SolutionSY9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb2
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSN9740d1b2-d140-4959-a94b-843d4bf139c21
892589morphine sulfate 2 MG/ML Oral SolutionSCD9740d1b2-d140-4959-a94b-843d4bf139c21
892589morphine sulfate 10 MG per 5 ML Oral SolutionSY9740d1b2-d140-4959-a94b-843d4bf139c21
892589MS 2 MG/ML Oral SolutionSY9740d1b2-d140-4959-a94b-843d4bf139c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0237-410005402374115 mL in 1 BOTTLE (0054-0237-41) 15 ml2014-09-090000-00-00NoNoCurrent
0054-0237-4900054023749100 mL in 1 BOTTLE (0054-0237-49) 100 ml2008-03-170000-00-00NoNoCurrent
0054-0237-55000540237555 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0054-0237-6300054023763500 mL in 1 BOTTLE (0054-0237-63) 500 ml2008-03-170000-00-00NoNoCurrent