FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0832-0226
11-digit product format
008320226
Labeler code
0832
Product ID
0832-0226_3984af25-b79e-1fe0-e063-6394a90ac936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA202104
Marketing category
ANDA
Marketing start
2013-06-30
Substance
MORPHINE SULFATE
Active strength
20 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 SULFATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892345, 892352, 892494, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0832-0226-00Morphine Sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10021
0832-0226-50Morphine Sulfate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0832-0226-00EA - Each0832-0226a2f11f6e-a85d-4afc-a9c3-0072509fe1db12013-09-04
0832-0226-50EA - Each0832-02266e1578fa-1cbd-4e3e-bc91-da6e9045ca4112013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Morphine SulfateACTIVE INGREDIENTX3P646A2J0MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
MorphineACTIVE MOIETY76I7G6D29CMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
diethyl phthalateINACTIVE INGREDIENTUF064M00AFMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
gelatinINACTIVE INGREDIENT2G86QN327LMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
polyethylene glycol 4000INACTIVE INGREDIENT4R4HFI6D95MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
talcINACTIVE INGREDIENT7SEV7J4R1UMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-0226MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]20Current NDC, Legacy NDC, 2 package rows20240407_97948a8f-7d1b-4614-b11d-e944cf56590b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892494morphine sulfate 10 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
892554morphine sulfate 100 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
892596morphine sulfate 20 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
892345morphine sulfate 30 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
894801morphine sulfate 50 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
892352morphine sulfate 60 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
894814morphine sulfate 80 MG Extended Release Oral CapsulePSN97948a8f-7d1b-4614-b11d-e944cf56590b21
892494morphine sulfate 10 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
892554morphine sulfate 100 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
892596morphine sulfate 20 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
892345morphine sulfate 30 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
894801morphine sulfate 50 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
892352morphine sulfate 60 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
894814morphine sulfate 80 MG Extended Release Oral CapsuleSCD97948a8f-7d1b-4614-b11d-e944cf56590b21
892352morphine sulfate 60 MG 12-24 HR Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
892494MS 10 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
892554MS 100 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
892596MS 20 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
892345MS 30 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
894801MS 50 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
892352MS 60 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21
894814MS 80 MG Extended Release Oral CapsuleSY97948a8f-7d1b-4614-b11d-e944cf56590b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-0226-0000832022600100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0226-00) 2013-06-300000-00-00NoNoCurrent
0832-0226-5000832022650500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0226-50) 2013-06-300000-00-00NoNoCurrent