FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
68094-256
11-digit product format
680940256
Labeler code
68094
Product ID
68094-256_0b6fccbe-0ef9-4395-9043-a1c8c219029f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
NDA022195
Marketing category
NDA
Marketing start
2023-08-15
Substance
MORPHINE SULFATE
Active strength
100 mg/5mL
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 SULFATE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892625

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
68094-256-01Morphine Sulfate0.5 mL in 1 SYRINGE, PLASTICSOLUTION0.52
68094-256-58Morphine Sulfate1 in 1 BAGSOLUTION12
68094-256-58Morphine Sulfate50 in 1 CASESOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-256MORPHINE SULFATE SOLUTION [PRECISION DOSE, INC.]2Current NDC, 3 package rows20241017_cc50d3c1-b4c8-4edc-9aa0-844d2fed45fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 20 MG/ML Oral SolutionSCDcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2
892625MS 20 MG/ML Oral SolutionSYcc50d3c1-b4c8-4edc-9aa0-844d2fed45fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-256-01680940256010.5 mL in 1 SYRINGE, PLASTIC0.5 mlHistorical
68094-256-586809402565850 BAG in 1 CASE (68094-256-58) / 1 SYRINGE, PLASTIC in 1 BAG / .5 mL in 1 SYRINGE, PLASTIC (68094-256-01) 50 bag2023-08-15NoNoHistorical