Morphine Sulfate

Product NDC
42858-812
11-digit product format
428580812
Labeler code
42858
Product ID
42858-812_ce2b7c6b-57bb-452e-8ce0-2a2e76a91599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Morphine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA206308
Marketing category
ANDA
Marketing start
2017-06-22
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-812-1242858081212120 mL in 1 BOTTLE, PLASTIC (42858-812-12) 120 ml2017-06-220000-00-00NoNoCurrent
42858-812-154285808121530 mL in 1 BOTTLE, PLASTIC (42858-812-15) 30 ml2017-06-220000-00-00NoNoCurrent