FDA.reportPublic FDA data

Morphine sulfate

Product NDC
71335-0736
11-digit product format
713350736
Labeler code
71335
Product ID
71335-0736_588e9565-16de-4b5d-b409-d081f5b50bd0
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
15 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 SULFATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891881

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
71335-0736-0Morphine sulfate26 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE26102
71335-0736-1Morphine sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30102
71335-0736-2Morphine sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE60102
71335-0736-3Morphine sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90102
71335-0736-4Morphine sulfate120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE120102
71335-0736-5Morphine sulfate40 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE40102
71335-0736-6Morphine sulfate14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE14102
71335-0736-7Morphine sulfate15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE15102
71335-0736-8Morphine sulfate20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE20102
71335-0736-9Morphine sulfate84 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE84102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0736-1EA - Each71335-0736036f06a5-664e-4512-87db-09e8ce9e63a612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0736MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240410_73a39ce5-b2ab-47b9-8860-796f1d5bc8d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891881morphine sulfate 15 MG Extended Release Oral TabletPSN73a39ce5-b2ab-47b9-8860-796f1d5bc8d8102
891881morphine sulfate 15 MG Extended Release Oral TabletSCD73a39ce5-b2ab-47b9-8860-796f1d5bc8d8102
891881MS 15 MG Extended Release Oral TabletSY73a39ce5-b2ab-47b9-8860-796f1d5bc8d8102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0736-07133507360026 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-0) 2024-04-030000-00-00NoNoCurrent
71335-0736-17133507360130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-1) 2018-03-160000-00-00NoNoCurrent
71335-0736-27133507360260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-2) 2018-03-280000-00-00NoNoCurrent
71335-0736-37133507360390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-3) 2018-04-130000-00-00NoNoCurrent
71335-0736-471335073604120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-4) 2024-04-030000-00-00NoNoCurrent
71335-0736-57133507360540 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-5) 2024-04-030000-00-00NoNoCurrent
71335-0736-67133507360614 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-6) 2024-04-030000-00-00NoNoCurrent
71335-0736-77133507360715 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-7) 2024-04-030000-00-00NoNoCurrent
71335-0736-87133507360820 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-8) 2024-04-030000-00-00NoNoCurrent
71335-0736-97133507360984 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0736-9) 2024-04-030000-00-00NoNoCurrent