FDA.reportPublic FDA data

MORPHINE SULFATE

Product NDC
0406-8380
11-digit product format
004068380
Labeler code
0406
Product ID
0406-8380_6873cac9-e7d5-4db2-851d-528268b483e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076412
Marketing category
ANDA
Marketing start
2003-07-31
Substance
MORPHINE SULFATE
Active strength
60 mg/1
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 SULFATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891874, 891881, 891888, 891893, 892646

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
0406-8380-01MORPHINE SULFATE100 in 1 BOTTLETABLET, EXTENDED RELEASE10038
0406-8380-23MORPHINE SULFATE1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE138
0406-8380-62MORPHINE SULFATE100 in 1 BLISTER PACKTABLET, EXTENDED RELEASE10038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8380-01EA - Each0406-838051fd738a-7a75-4406-a88b-59e2f6689b1b12012-07-24
0406-8380-23EA - Each0406-838066d2985a-8065-435c-b870-cad30029b35c12013-03-03
0406-8380-62EA - Each0406-8380e63f2f5e-3ab6-4b42-afe5-84d0c32ee45012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
TRIACETININACTIVE INGREDIENTXHX3C3X673MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]359
MORPHINE SULFATEACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
MORPHINEACTIVE MOIETY76I7G6D29CMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19
TRIACETININACTIVE INGREDIENTXHX3C3X673MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8380MORPHINE SULFATE TABLET, EXTENDED RELEASE [SPECGX LLC]38Current NDC, Legacy NDC, 3 package rows20240724_533034fd-c8e7-495b-8874-0db41bd1e65a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891893morphine sulfate 60 MG Extended Release Oral TabletPSN4bf994a4-6cc5-4941-8a81-6cf4c7ee235a359
891893morphine sulfate 60 MG Extended Release Oral TabletSCD4bf994a4-6cc5-4941-8a81-6cf4c7ee235a359
891893MS 60 MG Extended Release Oral TabletSY4bf994a4-6cc5-4941-8a81-6cf4c7ee235a359
891874morphine sulfate 100 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891881morphine sulfate 15 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
892646morphine sulfate 200 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891888morphine sulfate 30 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891893morphine sulfate 60 MG Extended Release Oral TabletPSN533034fd-c8e7-495b-8874-0db41bd1e65a38
891874morphine sulfate 100 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891881morphine sulfate 15 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
892646morphine sulfate 200 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891888morphine sulfate 30 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891893morphine sulfate 60 MG Extended Release Oral TabletSCD533034fd-c8e7-495b-8874-0db41bd1e65a38
891874MS 100 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
891881MS 15 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
892646MS 200 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
891888MS 30 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38
891893MS 60 MG Extended Release Oral TabletSY533034fd-c8e7-495b-8874-0db41bd1e65a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-8380-0100406838001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8380-01) 2003-07-310000-00-00NoNoCurrent
0406-8380-23004068380231 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8380-23) 2003-07-310000-00-00NoNoCurrent
0406-8380-6200406838062100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8380-62) 2003-07-310000-00-00NoNoCurrent