FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0832-0274
11-digit product format
008320274
Labeler code
0832
Product ID
0832-0274_46a682fc-0430-5a66-e063-6294a90a6179
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA210610
Marketing category
ANDA
Marketing start
2019-07-22
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
Rxcui892582, 892672

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
0832-0274-112025-12-23C16284748780-13b156c62-24d5-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
0832-0274-112025-07-29C16284748780-13b156c62-24d5-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0274-11Morphine Sulfate100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0274-11EA - Each0832-02744b970a3e-30df-4500-9e9f-ef66a84f03bc12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0274MORPHINE SULFATE TABLET [UPSHER-SMITH LABORATORIES, LLC]8Current NDC, Legacy NDC, 1 package rows20240423_5ceb3205-2f8d-4ba3-9f27-dc328bab4fa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892582morphine sulfate 15 MG Oral TabletPSN5ceb3205-2f8d-4ba3-9f27-dc328bab4fa19
892672morphine sulfate 30 MG Oral TabletPSN5ceb3205-2f8d-4ba3-9f27-dc328bab4fa19
892582morphine sulfate 15 MG Oral TabletSCD5ceb3205-2f8d-4ba3-9f27-dc328bab4fa19
892672morphine sulfate 30 MG Oral TabletSCD5ceb3205-2f8d-4ba3-9f27-dc328bab4fa19
892582MS 15 MG Oral TabletSY5ceb3205-2f8d-4ba3-9f27-dc328bab4fa19
892672MS 30 MG Oral TabletSY5ceb3205-2f8d-4ba3-9f27-dc328bab4fa19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0832-0274-1100832027411100 TABLET in 1 BOTTLE (0832-0274-11) 100 tablet2019-07-220000-00-00NoNoCurrent