FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0641-6125
11-digit product format
006416125
Labeler code
0641
Product ID
0641-6125_fa18221d-2353-4cf6-a210-fb33ee79d3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA205758
Marketing category
ANDA
Marketing start
2015-06-03
Substance
MORPHINE SULFATE
Active strength
4 mg/mL
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 SULFATE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui1731993, 1732006, 1732011

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
0641-6125-01Morphine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION110
0641-6125-25Morphine Sulfate25 in 1 PACKAGEINJECTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6125-01ML - Milliliter0641-612575725d7d-30d1-4bfa-8b3a-66ce1da7332c12015-10-02
0641-6125-25ML - Milliliter0641-61257b49fce7-e20f-4875-a872-f175820517d712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6125MORPHINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240608_6023606c-150c-40c5-9175-598efe2a56c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731993morphine sulfate 10 MG in 1 ML InjectionPSN6023606c-150c-40c5-9175-598efe2a56c310
1732006morphine sulfate 4 MG in 1 ML InjectionPSN6023606c-150c-40c5-9175-598efe2a56c310
1732011morphine sulfate 8 MG in 1 ML InjectionPSN6023606c-150c-40c5-9175-598efe2a56c310
17319931 ML morphine sulfate 10 MG/ML InjectionSCD6023606c-150c-40c5-9175-598efe2a56c310
17320061 ML morphine sulfate 4 MG/ML InjectionSCD6023606c-150c-40c5-9175-598efe2a56c310
17320111 ML morphine sulfate 8 MG/ML InjectionSCD6023606c-150c-40c5-9175-598efe2a56c310
17319931 ML MS 10 MG/ML InjectionSY6023606c-150c-40c5-9175-598efe2a56c310
17320061 ML MS 4 MG/ML InjectionSY6023606c-150c-40c5-9175-598efe2a56c310
17320111 ML MS 8 MG/ML InjectionSY6023606c-150c-40c5-9175-598efe2a56c310
1731993morphine sulfate 10 MG per 1 ML InjectionSY6023606c-150c-40c5-9175-598efe2a56c310
1732006morphine sulfate 4 MG per 1 ML InjectionSY6023606c-150c-40c5-9175-598efe2a56c310
1732011morphine sulfate 8 MG per 1 ML InjectionSY6023606c-150c-40c5-9175-598efe2a56c310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6125-01006416125011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0641-6125-250064161252525 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-6125-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-6125-01) 2015-06-030000-00-00NoNoCurrent