FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
68094-001
11-digit product format
680940001
Labeler code
68094
Product ID
68094-001_37f26dc3-093a-4f05-a71d-1f0e280d20b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose Inc.
Application
NDA022195
Marketing category
NDA
Marketing start
2016-02-29
Substance
MORPHINE SULFATE
Active strength
10 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892589

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
68094-001-59Morphine Sulfate5 mL in 1 CUP, UNIT-DOSESOLUTION59
68094-001-62Morphine Sulfate10 in 1 TRAYSOLUTION109
68094-001-62Morphine Sulfate3 in 1 CASESOLUTION39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-001-59ML - Milliliter68094-0015a08d1ef-30c6-4a78-a0f6-7de3992d6bb112016-03-04
68094-001-62ML - Milliliter68094-001610c3292-6502-4c69-9af8-32fd275687bc12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-001MORPHINE SULFATE SOLUTION [PRECISION DOSE INC.]8Current NDC, Legacy NDC, 3 package rows20241004_8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSN8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589morphine sulfate 2 MG/ML Oral SolutionSCD8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589morphine sulfate 10 MG per 5 ML Oral SolutionSY8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9
892589MS 2 MG/ML Oral SolutionSY8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-001-59680940001595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-001-62680940001623 TRAY in 1 CASE (68094-001-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-001-59) 3 tray2016-02-290000-00-00NoNoCurrent