FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
63323-452
11-digit product format
633230452
Labeler code
63323
Product ID
63323-452_dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA204223
Marketing category
NDA
Marketing start
2018-04-10
Substance
MORPHINE SULFATE
Active strength
2 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 SULFATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui1731993, 1732006, 1732011, 1732136, 2003714

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
63323-452-00Morphine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION16
63323-452-01Morphine Sulfate25 in 1 BOXINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-452-00ML - Milliliter63323-452471dfebf-1d38-4a45-bda3-9fb8d31ae62512018-06-11
63323-452-01ML - Milliliter63323-452990f1556-d055-4fbe-b5ae-96194b85f55a12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-452MORPHINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20250321_582f42e5-444e-4246-af8c-e7e28097c69a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731993morphine sulfate 10 MG in 1 ML InjectionPSN582f42e5-444e-4246-af8c-e7e28097c69a6
2003714morphine sulfate 2 MG in 1 ML InjectionPSN582f42e5-444e-4246-af8c-e7e28097c69a6
1732006morphine sulfate 4 MG in 1 ML InjectionPSN582f42e5-444e-4246-af8c-e7e28097c69a6
1732136morphine sulfate 5 MG in 1 ML InjectionPSN582f42e5-444e-4246-af8c-e7e28097c69a6
1732011morphine sulfate 8 MG in 1 ML InjectionPSN582f42e5-444e-4246-af8c-e7e28097c69a6
17319931 ML morphine sulfate 10 MG/ML InjectionSCD582f42e5-444e-4246-af8c-e7e28097c69a6
20037141 ML morphine sulfate 2 MG/ML InjectionSCD582f42e5-444e-4246-af8c-e7e28097c69a6
17320061 ML morphine sulfate 4 MG/ML InjectionSCD582f42e5-444e-4246-af8c-e7e28097c69a6
17321361 ML morphine sulfate 5 MG/ML InjectionSCD582f42e5-444e-4246-af8c-e7e28097c69a6
17320111 ML morphine sulfate 8 MG/ML InjectionSCD582f42e5-444e-4246-af8c-e7e28097c69a6
17319931 ML MS 10 MG/ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
20037141 ML MS 2 MG/ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
17320061 ML MS 4 MG/ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
17321361 ML MS 5 MG/ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
17320111 ML MS 8 MG/ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
1731993morphine sulfate 10 MG per 1 ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
2003714morphine sulfate 2 MG per 1 ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
1732006morphine sulfate 4 MG per 1 ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
1732136morphine sulfate 5 MG per 1 ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6
1732011morphine sulfate 8 MG per 1 ML InjectionSY582f42e5-444e-4246-af8c-e7e28097c69a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-452-00633230452001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-452-016332304520125 VIAL, SINGLE-DOSE in 1 BOX (63323-452-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-452-00) 2018-04-100000-00-00NoNoCurrent