Morphine Sulfate

Product NDC
76045-007
11-digit product format
760450007
Labeler code
76045
Product ID
76045-007_286bce70-23cd-4d5b-989b-230d6cdd5a91
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
2013-10-30
Substance
MORPHINE SULFATE
Active strength
8 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 SULFATE8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui894912, 894914, 998212, 998213, 1442790

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76045-007-01Morphine Sulfate1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION17
76045-007-11Morphine Sulfate10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-007-10ML - Milliliter76045-0075a8f9446-6314-4820-9364-da5f3ec4a9c012014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Morphine SulfateACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
MorphineACTIVE MOIETY76I7G6D29CMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE INJECTION, SOLUTION [BD RX INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-007MORPHINE SULFATE (MORPHINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]17Current NDC, Legacy NDC20210310_b62ee1ef-db55-417a-a02e-b103890f9c4b.zip
76045-007MORPHINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI, USA LLC]7Current NDC, Legacy NDC, 2 package rows20250412_1f53de80-efc8-4930-b3e3-fba0d026af05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
894912morphine sulfate 10 MG in 1 ML Prefilled SyringePSN1f53de80-efc8-4930-b3e3-fba0d026af057
998212morphine sulfate 2 MG in 1 ML Prefilled SyringePSN1f53de80-efc8-4930-b3e3-fba0d026af057
998213morphine sulfate 4 MG in 1 ML Prefilled SyringePSN1f53de80-efc8-4930-b3e3-fba0d026af057
1442790morphine sulfate 5 MG in 1 ML Prefilled SyringePSN1f53de80-efc8-4930-b3e3-fba0d026af057
894914morphine sulfate 8 MG in 1 ML Prefilled SyringePSN1f53de80-efc8-4930-b3e3-fba0d026af057
8949121 ML morphine sulfate 10 MG/ML Prefilled SyringeSCD1f53de80-efc8-4930-b3e3-fba0d026af057
9982121 ML morphine sulfate 2 MG/ML Prefilled SyringeSCD1f53de80-efc8-4930-b3e3-fba0d026af057
9982131 ML morphine sulfate 4 MG/ML Prefilled SyringeSCD1f53de80-efc8-4930-b3e3-fba0d026af057
14427901 ML morphine sulfate 5 MG/ML Prefilled SyringeSCD1f53de80-efc8-4930-b3e3-fba0d026af057
8949141 ML morphine sulfate 8 MG/ML Prefilled SyringeSCD1f53de80-efc8-4930-b3e3-fba0d026af057
8949121 ML MS 10 MG/ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
9982121 ML MS 2 MG/ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
9982131 ML MS 4 MG/ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
14427901 ML MS 5 MG/ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
8949141 ML MS 8 MG/ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
894912morphine sulfate 10 MG per 1 ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
998212morphine sulfate 2 MG per 1 ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
998213morphine sulfate 4 MG per 1 ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
1442790morphine sulfate 5 MG per 1 ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057
894914morphine sulfate 8 MG per 1 ML Prefilled SyringeSY1f53de80-efc8-4930-b3e3-fba0d026af057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-007-01760450007011 mL in 1 SYRINGE, GLASS1 mlHistorical
76045-007-107604500071024 BLISTER PACK in 1 CARTON (76045-007-10) > 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-007-00) > 1 mL in 1 SYRINGE, GLASS24 blister pack2013-10-300000-00-00NoNoCurrent
76045-007-117604500071110 SYRINGE, GLASS in 1 CARTON (76045-007-11) > 1 mL in 1 SYRINGE, GLASS (76045-007-01) 2019-11-250000-00-00NoNoCurrent