FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
27808-082
11-digit product format
278080082
Labeler code
27808
Product ID
27808-082_6c3bd932-ab35-4173-8087-f916e3d688ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
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
2027-12-31
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 SULFATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892589, 892625

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
27808-082-01Morphine Sulfate30 mL in 1 BOTTLE, UNIT-DOSESOLUTION3037
27808-082-01Morphine Sulfate1 in 1 CARTONSOLUTION137
27808-082-02Morphine Sulfate1 in 1 CARTONSOLUTION137
27808-082-02Morphine Sulfate120 mL in 1 BOTTLE, UNIT-DOSESOLUTION12037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-082-01ML - Milliliter27808-08244991d91-8114-4127-8743-f396e023c3ad12015-11-12
27808-082-02ML - Milliliter27808-0821391b655-869d-4d40-afd4-57a535cbe0a512015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
SORBITOLINACTIVE INGREDIENT506T60A25RMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE SOLUTION [TRIS PHARMA INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-082MORPHINE SULFATE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]35Current NDC, Legacy NDC, 4 package rows20250507_d8598654-94ad-4cfb-81d2-9b68e013a428.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN9bb1fef7-4159-4dca-8a8c-37e53ccc6bab104
892625morphine sulfate 20 MG/ML Oral SolutionSCD9bb1fef7-4159-4dca-8a8c-37e53ccc6bab104
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY9bb1fef7-4159-4dca-8a8c-37e53ccc6bab104
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY9bb1fef7-4159-4dca-8a8c-37e53ccc6bab104
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY9bb1fef7-4159-4dca-8a8c-37e53ccc6bab104
892625MS 20 MG/ML Oral SolutionSY9bb1fef7-4159-4dca-8a8c-37e53ccc6bab104
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
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSN367d508b-3226-42a9-8dc6-f67cdc9979f3102
892625morphine sulfate 20 MG/ML Oral SolutionSCD367d508b-3226-42a9-8dc6-f67cdc9979f3102
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSY367d508b-3226-42a9-8dc6-f67cdc9979f3102
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSY367d508b-3226-42a9-8dc6-f67cdc9979f3102
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSY367d508b-3226-42a9-8dc6-f67cdc9979f3102
892625MS 20 MG/ML Oral SolutionSY367d508b-3226-42a9-8dc6-f67cdc9979f3102
892589morphine sulfate 10 MG in 5 mL Oral SolutionPSNd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 20 MG in 1 mL Concentrate for Oral SolutionPSNd8598654-94ad-4cfb-81d2-9b68e013a42837
892589morphine sulfate 2 MG/ML Oral SolutionSCDd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 20 MG/ML Oral SolutionSCDd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 10 MG per 0.5 ML Concentrate for Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892589morphine sulfate 10 MG per 5 ML Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 100 MG per 5 ML Concentrate for Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892625morphine sulfate 20 MG/ML Concentrate for Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892589MS 2 MG/ML Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837
892625MS 20 MG/ML Oral SolutionSYd8598654-94ad-4cfb-81d2-9b68e013a42837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27808-082-01278080082011 BOTTLE, UNIT-DOSE in 1 CARTON (27808-082-01) / 30 mL in 1 BOTTLE, UNIT-DOSE2015-09-210000-00-00NoNoCurrent
27808-082-02278080082021 BOTTLE, UNIT-DOSE in 1 CARTON (27808-082-02) / 120 mL in 1 BOTTLE, UNIT-DOSE2015-09-210000-00-00NoNoCurrent