Morphine Sulfate

Product NDC
63629-2302
11-digit product format
636292302
Labeler code
63629
Product ID
63629-2302_9e0944d6-c816-4d0e-97bd-31b3eaf011f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203518
Marketing category
ANDA
Marketing start
2015-09-21
Substance
MORPHINE SULFATE
Active strength
20 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 SULFATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892625

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
63629-2302-1Morphine Sulfate1 in 1 CARTONSOLUTION1103
63629-2302-1Morphine Sulfate120 mL in 1 BOTTLE, UNIT-DOSESOLUTION120103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2302-1ML - Milliliter63629-2302c69aebdf-7449-4e4c-bb40-6c1cff2e336d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2302MORPHINE SULFATE SOLUTION [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20230306_b7b86b6d-9a39-494c-bf65-f62e4cdc5807.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNb7b86b6d-9a39-494c-bf65-f62e4cdc5807103
892625morphine sulfate 20 MG/ML Oral SolutionSCDb7b86b6d-9a39-494c-bf65-f62e4cdc5807103
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYb7b86b6d-9a39-494c-bf65-f62e4cdc5807103
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYb7b86b6d-9a39-494c-bf65-f62e4cdc5807103
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYb7b86b6d-9a39-494c-bf65-f62e4cdc5807103
892625MS 20 MG/ML Oral SolutionSYb7b86b6d-9a39-494c-bf65-f62e4cdc5807103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2302-1636292302011 BOTTLE, UNIT-DOSE in 1 CARTON (63629-2302-1) / 120 mL in 1 BOTTLE, UNIT-DOSE2015-09-210000-00-00NoNoCurrent