FDA.reportPublic FDA data

Morphine sulfate

Product NDC
71335-0707
11-digit product format
713350707
Labeler code
71335
Product ID
71335-0707_1232954b-d43d-4060-8876-86e38a14f8d9
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
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
Rxcui891893

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
71335-0707-1Morphine sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30103
71335-0707-2Morphine sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE60103
71335-0707-3Morphine sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90103
71335-0707-4Morphine sulfate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE120103
71335-0707-5Morphine sulfate5 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5103
71335-0707-6Morphine sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100103
71335-0707-7Morphine sulfate28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE28103
71335-0707-8Morphine sulfate8 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE8103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0707-1EA - Each71335-0707d7683c82-3a94-4381-b064-6b84db99712312018-08-13
71335-0707-6EA - Each71335-070787803941-de05-40e4-8166-4cf146c220c612025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0707MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 8 package rows20240410_47ea2424-ce2f-4b3b-b393-da1886e7a383.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891893morphine sulfate 60 MG Extended Release Oral TabletPSN47ea2424-ce2f-4b3b-b393-da1886e7a383103
891893morphine sulfate 60 MG Extended Release Oral TabletSCD47ea2424-ce2f-4b3b-b393-da1886e7a383103
891893MS 60 MG Extended Release Oral TabletSY47ea2424-ce2f-4b3b-b393-da1886e7a383103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0707-17133507070130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-1) 2018-02-260000-00-00NoNoCurrent
71335-0707-27133507070260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-2) 2018-02-270000-00-00NoNoCurrent
71335-0707-37133507070390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-3) 2024-01-020000-00-00NoNoCurrent
71335-0707-471335070704120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-4) 2024-04-030000-00-00NoNoCurrent
71335-0707-5713350707055 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-5) 2024-04-030000-00-00NoNoCurrent
71335-0707-671335070706100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-6) 2024-04-030000-00-00NoNoCurrent
71335-0707-77133507070728 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-7) 2024-04-030000-00-00NoNoCurrent
71335-0707-8713350707088 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0707-8) 2024-04-030000-00-00NoNoCurrent