FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
72162-1352
11-digit product format
721621352
Labeler code
72162
Product ID
72162-1352_3142315d-d688-405d-962a-c684f7e6e7a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074769
Marketing category
ANDA
Marketing start
2011-01-14
Substance
MORPHINE SULFATE
Active strength
200 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
Brand name suffix
Extended Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui892646

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
72162-1352-1Morphine SulfateExtended Release100 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1352-1EA - Each72162-135264c18b83-70cb-4e41-82ec-a268c5a63a5712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1352MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240208_c94d9da6-7a12-44ee-a38f-3323ee27842c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892646morphine sulfate 200 MG Extended Release Oral TabletPSNc94d9da6-7a12-44ee-a38f-3323ee27842c101
892646morphine sulfate 200 MG Extended Release Oral TabletSCDc94d9da6-7a12-44ee-a38f-3323ee27842c101
892646MS 200 MG Extended Release Oral TabletSYc94d9da6-7a12-44ee-a38f-3323ee27842c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1352-172162135201100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72162-1352-1) 2026-04-03NoNoHistorical