FDA.reportPublic FDA data

Morphine sulfate

Product NDC
72162-1791
11-digit product format
721621791
Labeler code
72162
Product ID
72162-1791_0c6a93c2-80bb-47dc-9a64-717724b23302
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078761
Marketing category
ANDA
Marketing start
2012-05-11
Marketing end
2026-12-31
Substance
MORPHINE SULFATE
Active strength
100 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Morphine sulfate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MORPHINE SULFATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX3P646A2J0
Rxcui891874

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
72162-1791-1Morphine sulfate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100103
72162-1791-3Morphine sulfate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30103
72162-1791-6Morphine sulfate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE60103
72162-1791-9Morphine sulfate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1791-1EA - Each72162-17915ceb4bcd-d678-4636-8885-f99dcf1b431912023-10-16
72162-1791-3EA - Each72162-17916bed34b4-4b48-4ec3-b646-dc5b12eebaab12023-10-16
72162-1791-6EA - Each72162-17912484c89b-653b-495d-ab78-bf6a39c8b95512023-10-16
72162-1791-9EA - Each72162-1791e826a876-2188-4cb1-bf2a-b6b94965f8ce12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1791MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20240821_3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891874morphine sulfate 100 MG Extended Release Oral TabletPSN3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226103
891874morphine sulfate 100 MG Extended Release Oral TabletSCD3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226103
891874MS 100 MG Extended Release Oral TabletSY3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72162-1791-172162179101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-1791-1) 2012-05-112026-12-31NoNoHistorical
72162-1791-37216217910330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-1791-3) 2012-05-112026-12-31NoNoHistorical
72162-1791-67216217910660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-1791-6) 2012-05-112026-12-31NoNoHistorical
72162-1791-97216217910990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-1791-9) 2012-05-112026-12-31NoNoHistorical