FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
17856-0517
11-digit product format
178560517
Labeler code
17856
Product ID
17856-0517_6e52f354-e4bd-4fed-b733-14d48b06cd97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
NDA022195
Marketing category
NDA
Marketing start
2008-03-17
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0517-12025-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-22025-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-32025-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-42025-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-12023-06-15C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-22023-06-15C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-32023-06-15C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-42023-06-15C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-12023-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-22023-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-32023-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-42023-01-30C16284748780-1f386c64a-04ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0517-1Morphine Sulfate60 in 1 BOX, UNIT-DOSESOLUTION604
17856-0517-2Morphine Sulfate120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-0517-3Morphine Sulfate120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-0517-4Morphine Sulfate120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-0517-5Morphine Sulfate0.25 mL in 1 SYRINGESOLUTION0.254
17856-0517-6Morphine Sulfate1.0 mL in 1 SYRINGESOLUTION1.04
17856-0517-7Morphine Sulfate0.25 mL in 1 SYRINGESOLUTION0.254
17856-0517-8Morphine Sulfate1 mL in 1 SYRINGESOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0517MORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 8 package rows20230616_839923b4-4b4c-4745-baa5-4d27d4dbb5e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 20 MG/ML Oral SolutionSCD839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74
892625MS 20 MG/ML Oral SolutionSY839923b4-4b4c-4745-baa5-4d27d4dbb5e74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0517-11785605170160 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-1) > .25 mL in 1 SYRINGE60 syringe2021-01-070000-00-00NoNoCurrent
17856-0517-217856051702120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-2) > 1 mL in 1 SYRINGE120 syringe2021-01-070000-00-00NoNoCurrent
17856-0517-317856051703120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-3) > .25 mL in 1 SYRINGE120 syringe2021-01-070000-00-00NoNoCurrent
17856-0517-417856051704120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-4) > 1 mL in 1 SYRINGE120 syringe2021-03-100000-00-00NoNoCurrent
17856-0517-5178560517050.25 mL in 1 SYRINGE0.25 mlHistorical
17856-0517-6178560517061.0 mL in 1 SYRINGE1.0 mlHistorical
17856-0517-7178560517070.25 mL in 1 SYRINGE0.25 mlHistorical
17856-0517-8178560517081 mL in 1 SYRINGE1 mlHistorical