FDA.reportPublic FDA data

Morphine sulfate

Product NDC
0228-3116
11-digit product format
002283116
Labeler code
0228
Product ID
0228-3116_d41b3be8-7ef7-4b1d-9692-fffd13baf96d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA079040
Marketing category
ANDA
Marketing start
2014-02-04
Substance
MORPHINE SULFATE
Active strength
45 mg/1
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 SULFATE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892297, 892342, 892349, 892355, 894942, 894970

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0228-3116-11Morphine sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10047

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ALCOHOLINACTIVE INGREDIENT3K9958V90MMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
AMMONIAINACTIVE INGREDIENT5138Q19F1XMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
GELATININACTIVE INGREDIENT2G86QN327LMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
SHELLACINACTIVE INGREDIENT46N107B71OMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
SUCROSEINACTIVE INGREDIENTC151H8M554MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TALCINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18
WATERINACTIVE INGREDIENT059QF0KO0RMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-3116MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]43Current NDC, Legacy NDC, 1 package rows20250418_2da87bfa-11fd-43e3-8fef-d16ebeb15680.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892297morphine sulfate 120 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892342morphine sulfate 30 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894942morphine sulfate 45 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892349morphine sulfate 60 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894970morphine sulfate 75 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892355morphine sulfate 90 MG 24HR Extended Release Oral CapsulePSN2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89229724 HR morphine sulfate 120 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234224 HR morphine sulfate 30 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89494224 HR morphine sulfate 45 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234924 HR morphine sulfate 60 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89497024 HR morphine sulfate 75 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89235524 HR morphine sulfate 90 MG Extended Release Oral CapsuleSCD2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89229724 HR MS 120 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234224 HR MS 30 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89494224 HR MS 45 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89234924 HR MS 60 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89497024 HR MS 75 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
89235524 HR MS 90 MG Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892297morphine sulfate 120 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892342morphine sulfate 30 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894942morphine sulfate 45 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892349morphine sulfate 60 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
894970morphine sulfate 75 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047
892355morphine sulfate 90 MG 24 HR Extended Release Oral CapsuleSY2da87bfa-11fd-43e3-8fef-d16ebeb1568047

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-3116-1100228311611100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3116-11) 2014-02-040000-00-00NoNoCurrent