Prescription Drug Information: Morphine Sulfate (Page 5 of 5)

MORPHINE SULFATE SOLUTION

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MORPHINE SULFATE SOLUTION

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MORPHINE SULFATE SOLUTION

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MORPHINE SULFATE morphine sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0238(NDC:0054-0238)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MORPHINE SULFATE (MORPHINE) MORPHINE SULFATE 20 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C GREEN NO. 3
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
SODIUM BENZOATE
SORBITOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0238-5 5 mL in 1 CUP, UNIT-DOSE None
2 NDC:17856-0238-1 60 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
2 1.25 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0238-1)
3 NDC:17856-0238-2 60 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
3 2.5 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0238-2)
4 NDC:17856-0238-3 60 SYRINGE in 1 BOX, UNIT-DOSE contains a SYRINGE
4 5 mL in 1 SYRINGE This package is contained within the BOX, UNIT-DOSE (17856-0238-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022195 03/17/2008
Labeler — ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
Name Address ID/FEI Operations
ATLANTIC BIOLOGICALS CORP. 047437707 RELABEL (17856-0238), REPACK (17856-0238)

Revised: 09/2021 ATLANTIC BIOLOGICALS CORP.

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