morphine sulfate

Product NDC
50383-965
11-digit product format
503830965
Labeler code
50383
Product ID
50383-965_6ce343da-e8ee-4220-b734-835884e752a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
morphine sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA208809
Marketing category
ANDA
Marketing start
2017-07-06
Marketing end
0000-00-00
Substance
MORPHINE SULFATE
Active strength
100 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-965-04ML - Milliliter50383-9657e7b8a7f-2e86-4510-a9f7-a9fe168a27ff12018-01-12
50383-965-30ML - Milliliter50383-9652facbf8b-322a-4f02-9809-29817026a9d712018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-965MORPHINE SULFATE SOLUTION [AKORN]10Legacy NDC20221116_431a06fb-b6e3-4aab-a965-6b90ad8b5aa5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-965-04503830965041 BOTTLE in 1 CARTON (50383-965-04) > 120 mL in 1 BOTTLE1 bottle2017-07-060000-00-00NoNoCurrent
50383-965-30503830965301 BOTTLE in 1 CARTON (50383-965-30) > 30 mL in 1 BOTTLE1 bottle2017-07-060000-00-00NoNoCurrent