FDA.reportPublic FDA data

Morphine sulfate

Product NDC
71335-0676
11-digit product format
713350676
Labeler code
71335
Product ID
71335-0676_f5c39af8-abf3-4860-8da0-c1b3ca79e66d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078761
Marketing category
ANDA
Marketing start
2012-05-11
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
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 SULFATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891888

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
71335-0676-0Morphine sulfate40 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE408
71335-0676-1Morphine sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
71335-0676-2Morphine sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
71335-0676-3Morphine sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908
71335-0676-4Morphine sulfate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1208
71335-0676-5Morphine sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
71335-0676-6Morphine sulfate5 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE58
71335-0676-7Morphine sulfate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE158
71335-0676-8Morphine sulfate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE208
71335-0676-9Morphine sulfate26 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE268

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0676-1EA - Each71335-067680f5d187-a986-4351-b488-33619623c0b712022-02-07
71335-0676-2EA - Each71335-06762ea866eb-1431-4e28-874a-6f9156e9c97e12022-02-07
71335-0676-3EA - Each71335-0676751fa7df-69b9-4fa2-95f3-5f202713f1b312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0676MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240412_ad08cd86-3825-4e77-bbe8-f6333a9ca9d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891888morphine sulfate 30 MG Extended Release Oral TabletPSNad08cd86-3825-4e77-bbe8-f6333a9ca9d78
891888morphine sulfate 30 MG Extended Release Oral TabletSCDad08cd86-3825-4e77-bbe8-f6333a9ca9d78
891888MS 30 MG Extended Release Oral TabletSYad08cd86-3825-4e77-bbe8-f6333a9ca9d78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0676-07133506760040 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-0) 2024-04-030000-00-00NoNoCurrent
71335-0676-17133506760130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-1) 2018-02-260000-00-00NoNoCurrent
71335-0676-27133506760260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-2) 2018-02-200000-00-00NoNoCurrent
71335-0676-37133506760390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-3) 2018-03-090000-00-00NoNoCurrent
71335-0676-471335067604120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-4) 2024-04-030000-00-00NoNoCurrent
71335-0676-571335067605100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-5) 2024-04-030000-00-00NoNoCurrent
71335-0676-6713350676065 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-6) 2024-04-030000-00-00NoNoCurrent
71335-0676-77133506760715 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-7) 2024-04-030000-00-00NoNoCurrent
71335-0676-87133506760820 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-8) 2024-04-030000-00-00NoNoCurrent
71335-0676-97133506760926 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-9) 2024-04-030000-00-00NoNoCurrent