Morphine Sulfate

Product NDC
0121-0825
11-digit product format
001210825
Labeler code
0121
Product ID
0121-0825_fb581fb2-a860-4eb7-a222-9ee0db19e178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MORPHINE SULFATE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI
Application
ANDA206573
Marketing category
ANDA
Marketing start
2016-11-14
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0825-01ML - Milliliter0121-0825693f0af6-6fb1-4a4b-9122-ac37a8ad218d12018-08-13
0121-0825-04ML - Milliliter0121-0825a6a6ba1c-0861-4fd4-bfde-0fc0c088f5f012018-08-13
0121-0825-08ML - Milliliter0121-0825c3beaf40-13cd-45e7-b5e7-3494138fa57b12022-05-04
0121-0825-15ML - Milliliter0121-0825318c5011-6a19-4fde-b178-d3f8c9d1c39c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0825MORPHINE SULFATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]17Legacy NDC20250507_9405556c-20e0-4e47-b1b0-7872bcc6517e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0825-010012108250130 mL in 1 BOTTLE (0121-0825-01) 30 ml2016-11-140000-00-00NoNoCurrent
0121-0825-0400121082504118 mL in 1 BOTTLE (0121-0825-04) 118 ml2016-11-140000-00-00NoNoCurrent
0121-0825-0800121082508240 mL in 1 BOTTLE (0121-0825-08) 240 ml2016-11-140000-00-00NoNoCurrent
0121-0825-15001210825151 BOTTLE in 1 CARTON (0121-0825-15) > 15 mL in 1 BOTTLE1 bottle2022-10-120000-00-00NoNoCurrent