MORPHINE SULFATE

Product NDC
61919-966
11-digit product format
619190966
Labeler code
61919
Product ID
61919-966_9ca97f1d-b268-ece1-e053-2995a90af53f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA074862
Marketing category
ANDA
Marketing start
2019-07-17
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
61919-966-302022-01-28C16284748780-1d6a99b39-9fea-a426-e053-dadaa90af4c2MORPHINE SULFATE EXTENDED RELEASE
61919-966-602020-01-31C16284748780-19d75b9d0-4d05-f424-e053-dadaa90a57ceMORPHINE SULFATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-966-30MORPHINE SULFATE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
61919-966-60MORPHINE SULFATE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-966-30EA - Each61919-96677075224-12a2-4da4-b66b-c5eea3fa049f12019-08-06
61919-966-60EA - Each61919-9664840b3b6-4de5-4bfc-ae65-44eff393fea412015-08-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-966MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX]3Legacy NDC, 1 package rows20200122_8de0a829-3d3c-9001-e053-2a95a90a9723.zip
61919-966MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]2Legacy NDC, 1 package rows20150911_14da9360-2be2-4897-896a-f9739c1b0441.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891881morphine sulfate 15 MG Extended Release Oral TabletPSN8de0a829-3d3c-9001-e053-2a95a90a97233
891881morphine sulfate 15 MG Extended Release Oral TabletSCD8de0a829-3d3c-9001-e053-2a95a90a97233
891881MS 15 MG Extended Release Oral TabletSY8de0a829-3d3c-9001-e053-2a95a90a97233
891881morphine sulfate 15 MG Extended Release Oral TabletPSN14da9360-2be2-4897-896a-f9739c1b04412
891881morphine sulfate 15 MG Extended Release Oral TabletSCD14da9360-2be2-4897-896a-f9739c1b04412
891881MS 15 MG Extended Release Oral TabletSY14da9360-2be2-4897-896a-f9739c1b04412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-966-306191909663030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-966-30) 2019-07-170000-00-00NoNoCurrent
61919-966-606191909666060 in 1 BOTTLEHistorical