Morphine Sulfate

Product NDC
0409-1896
11-digit product format
004091896
Labeler code
0409
Product ID
0409-1896_6f2d5741-5543-4bea-8d1d-7e4889b634a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA202515
Marketing category
NDA
Marketing start
2023-11-20
Substance
MORPHINE SULFATE
Active strength
50 mg/mL
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 SULFATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui1731537, 1731545

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
0409-1896-20Morphine Sulfate20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION207
0409-1896-20Morphine Sulfate1 in 1 CARTONINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1896-20ML - Milliliter0409-18965e911c46-cb4a-4636-a1ba-8c317f3ea93512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1896MORPHINE SULFATE INJECTION, SOLUTION MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]5Current NDC, 2 package rows20250425_ee8057d1-ed12-4e18-9efa-d83504abf612.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731537morphine sulfate 1 GM in 20 ML InjectionPSNee8057d1-ed12-4e18-9efa-d83504abf6127
1731545morphine sulfate 2.5 GM in 50 ML InjectionPSNee8057d1-ed12-4e18-9efa-d83504abf6127
173153720 ML morphine sulfate 50 MG/ML InjectionSCDee8057d1-ed12-4e18-9efa-d83504abf6127
173154550 ML morphine sulfate 50 MG/ML InjectionSCDee8057d1-ed12-4e18-9efa-d83504abf6127
173153720 ML MS 50 MG/ML InjectionSYee8057d1-ed12-4e18-9efa-d83504abf6127
173154550 ML MS 50 MG/ML InjectionSYee8057d1-ed12-4e18-9efa-d83504abf6127
1731537morphine sulfate 1 GM per 20 ML InjectionSYee8057d1-ed12-4e18-9efa-d83504abf6127
1731545morphine sulfate 2.5 GM per 50 ML InjectionSYee8057d1-ed12-4e18-9efa-d83504abf6127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0409-1896-20004091896201 VIAL, SINGLE-DOSE in 1 CARTON (0409-1896-20) / 20 mL in 1 VIAL, SINGLE-DOSE2023-11-20NoNoHistorical