FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
42689-006
11-digit product format
426890006
Labeler code
42689
Product ID
42689-006_863bb977-9d7b-4258-a6ff-3ed2eeefeb81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Nortec Development Associates, Inc.
Application
ANDA203158
Marketing category
ANDA
Marketing start
2009-04-07
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
Rxcui892345, 892352, 892554, 892596, 894801, 894814

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42689-006-012023-01-24C16284748780-1e4f33bdf-9e75-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use MORPHINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MORPHINE SULFATE EXTENDED-RELEASE CAPSULES. MORPHINE SULFATE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1941
42689-006-012022-07-29C16284748780-1e4f33bdf-9e75-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use MORPHINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MORPHINE SULFATE EXTENDED-RELEASE CAPSULES. MORPHINE SULFATE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42689-006-01Morphine Sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42689-006MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC.]15Current NDC, Legacy NDC, 1 package rows20231104_9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892554morphine sulfate 100 MG Extended Release Oral CapsulePSN9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892596morphine sulfate 20 MG Extended Release Oral CapsulePSN9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892345morphine sulfate 30 MG Extended Release Oral CapsulePSN9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
894801morphine sulfate 50 MG Extended Release Oral CapsulePSN9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892352morphine sulfate 60 MG Extended Release Oral CapsulePSN9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
894814morphine sulfate 80 MG Extended Release Oral CapsulePSN9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892554morphine sulfate 100 MG Extended Release Oral CapsuleSCD9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892596morphine sulfate 20 MG Extended Release Oral CapsuleSCD9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892345morphine sulfate 30 MG Extended Release Oral CapsuleSCD9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
894801morphine sulfate 50 MG Extended Release Oral CapsuleSCD9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892352morphine sulfate 60 MG Extended Release Oral CapsuleSCD9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
894814morphine sulfate 80 MG Extended Release Oral CapsuleSCD9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892352morphine sulfate 60 MG 12-24 HR Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892554MS 100 MG Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892596MS 20 MG Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892345MS 30 MG Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
894801MS 50 MG Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
892352MS 60 MG Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416
894814MS 80 MG Extended Release Oral CapsuleSY9c1a5b8b-8faa-4ee0-80bd-853c239bb1c416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42689-006-0142689000601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-006-01) 2009-04-070000-00-00NoNoCurrent