FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
0115-1279
11-digit product format
001151279
Labeler code
0115
Product ID
0115-1279_b2330bfc-8b32-421e-ade5-2076ee23cebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200411
Marketing category
ANDA
Marketing start
2016-04-12
Substance
MORPHINE SULFATE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892345, 892352, 892554, 892596, 894801, 894814, 1303736

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
0115-1279-01Morphine Sulfate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10042
0115-1279-03Morphine Sulfate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100042
0115-1279-08Morphine Sulfate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3042

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1279MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]37Current NDC, Legacy NDC, 3 package rows20240215_f7e9a4b3-a2ee-4f0a-becd-6ef90867332b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892554morphine sulfate 100 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892596morphine sulfate 20 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892345morphine sulfate 30 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
1303736morphine sulfate 40 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894801morphine sulfate 50 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352morphine sulfate 60 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894814morphine sulfate 80 MG Extended Release Oral CapsulePSNf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892554morphine sulfate 100 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892596morphine sulfate 20 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892345morphine sulfate 30 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
1303736morphine sulfate 40 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894801morphine sulfate 50 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352morphine sulfate 60 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894814morphine sulfate 80 MG Extended Release Oral CapsuleSCDf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352morphine sulfate 60 MG 12-24 HR Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892554MS 100 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892596MS 20 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892345MS 30 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
1303736MS 40 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894801MS 50 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
892352MS 60 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42
894814MS 80 MG Extended Release Oral CapsuleSYf7e9a4b3-a2ee-4f0a-becd-6ef90867332b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1279-0100115127901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-01) 2016-04-120000-00-00NoNoCurrent
0115-1279-03001151279031000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-03) 2016-04-120000-00-00NoNoCurrent
0115-1279-080011512790830 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-08) 2016-04-120000-00-00NoNoCurrent