FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0409-1891
11-digit product format
004091891
Labeler code
0409
Product ID
0409-1891_56671cfe-7548-442e-a2b5-ffebebf65ade
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA202515
Marketing category
NDA
Marketing start
2012-08-07
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
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 SULFATE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui894912, 998212, 998213, 1729197, 1731995, 1732014

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
0409-1891-01Morphine Sulfate10 in 1 CARTONINJECTION, SOLUTION1026
0409-1891-03Morphine Sulfate1 mL in 1 CARTRIDGEINJECTION, SOLUTION126
0409-1891-13Morphine Sulfate1 mL in 1 SYRINGEINJECTION, SOLUTION126
0409-1891-23Morphine Sulfate10 in 1 CELLO PACKINJECTION, SOLUTION1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1891-01ML - Milliliter0409-18918497ec6c-7173-41e0-ab9c-0c26629162e512013-02-13
0409-1891-03ML - Milliliter0409-18913538a468-695f-4c48-9370-9739c4e9989a12016-12-07
0409-1891-10ML - Milliliter0409-1891c8e30a04-eabf-4875-bce9-07c59eee463c12016-12-07
0409-1891-13ML - Milliliter0409-1891004a33ae-0770-4b12-86a9-d728ca6c2ae312021-03-02
0409-1891-23ML - Milliliter0409-1891ed22d4bd-5263-4a1c-a480-7a7aaf0ea61212021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1891MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 4 package rows20240103_be420e8b-bcb0-49b5-bb4d-1df8b9959809.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731995morphine sulfate 10 MG in 1 ML CartridgePSNbe420e8b-bcb0-49b5-bb4d-1df8b995980926
894912morphine sulfate 10 MG in 1 ML Prefilled SyringePSNbe420e8b-bcb0-49b5-bb4d-1df8b995980926
1729197morphine sulfate 2 MG in 1 ML CartridgePSNbe420e8b-bcb0-49b5-bb4d-1df8b995980926
998212morphine sulfate 2 MG in 1 ML Prefilled SyringePSNbe420e8b-bcb0-49b5-bb4d-1df8b995980926
1732014morphine sulfate 4 MG in 1 ML CartridgePSNbe420e8b-bcb0-49b5-bb4d-1df8b995980926
998213morphine sulfate 4 MG in 1 ML Prefilled SyringePSNbe420e8b-bcb0-49b5-bb4d-1df8b995980926
17319951 ML morphine sulfate 10 MG/ML CartridgeSCDbe420e8b-bcb0-49b5-bb4d-1df8b995980926
8949121 ML morphine sulfate 10 MG/ML Prefilled SyringeSCDbe420e8b-bcb0-49b5-bb4d-1df8b995980926
17291971 ML morphine sulfate 2 MG/ML CartridgeSCDbe420e8b-bcb0-49b5-bb4d-1df8b995980926
9982121 ML morphine sulfate 2 MG/ML Prefilled SyringeSCDbe420e8b-bcb0-49b5-bb4d-1df8b995980926
17320141 ML morphine sulfate 4 MG/ML CartridgeSCDbe420e8b-bcb0-49b5-bb4d-1df8b995980926
9982131 ML morphine sulfate 4 MG/ML Prefilled SyringeSCDbe420e8b-bcb0-49b5-bb4d-1df8b995980926
17319951 ML MS 10 MG/ML CartridgeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
8949121 ML MS 10 MG/ML Prefilled SyringeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
17291971 ML MS 2 MG/ML CartridgeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
9982121 ML MS 2 MG/ML Prefilled SyringeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
17320141 ML MS 4 MG/ML CartridgeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
9982131 ML MS 4 MG/ML Prefilled SyringeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
1731995morphine sulfate 10 mg per 1 ML CartridgeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
894912morphine sulfate 10 MG per 1 ML Prefilled SyringeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
1729197morphine sulfate 2 MG per 1 ML CartridgeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
998212morphine sulfate 2 MG per 1 ML Prefilled SyringeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
1732014morphine sulfate 4 MG per 1 ML CartridgeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926
998213morphine sulfate 4 MG per 1 ML Prefilled SyringeSYbe420e8b-bcb0-49b5-bb4d-1df8b995980926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1891-010040918910110 CARTRIDGE in 1 CARTON (0409-1891-01) / 1 mL in 1 CARTRIDGE (0409-1891-03) 10 cartridge2012-08-070000-00-00NoNoCurrent
0409-1891-03004091891031 mL in 1 CARTRIDGE1 mlHistorical
0409-1891-13004091891131 mL in 1 SYRINGE1 mlHistorical
0409-1891-230040918912310 SYRINGE in 1 CELLO PACK (0409-1891-23) / 1 mL in 1 SYRINGE (0409-1891-13) 10 syringe2021-02-012026-07-31NoNoCurrent