FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0904-6558
11-digit product format
009046558
Labeler code
0904
Product ID
0904-6558_a1b7bb1a-5dfd-49bb-acf4-15295726a48f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA074862
Marketing category
ANDA
Marketing start
2011-01-14
Substance
MORPHINE SULFATE
Active strength
30 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
Brand name suffix
Extended Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE30 mg/1

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
0904-6558-61Morphine SulfateExtended Release1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE110
0904-6558-61Morphine SulfateExtended Release100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6558-61EA - Each0904-6558729b9957-8512-4e9f-abed-41738adc06df12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6558MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20240704_dbb37dfd-0196-45f7-b9ca-393f56cf1d28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891881morphine sulfate 15 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891888morphine sulfate 30 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891893morphine sulfate 60 MG Extended Release Oral TabletPSNdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891874morphine sulfate 100 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891881morphine sulfate 15 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891888morphine sulfate 30 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891893morphine sulfate 60 MG Extended Release Oral TabletSCDdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891874MS 100 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891881MS 15 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891888MS 30 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810
891893MS 60 MG Extended Release Oral TabletSYdbb37dfd-0196-45f7-b9ca-393f56cf1d2810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6558-6100904655861100 BLISTER PACK in 1 CARTON (0904-6558-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2011-01-140000-00-00NoNoCurrent