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NDC 83270-002-01

Carboprost Tromethamine Injection, USP 250 mcg/mL

For Intramuscular use only

Rx Only

1 mL

NDC83270-002-02

Contains 10 of NDC 83270-002-01

Carboprost Tromethamine Injection, USP 250 mcg/mL

For Intramuscular use only

10 x 1 mL Single-Dose Vials

Rx Only Steriscience

HOW SUPPLIED

Carboprost tromethamine injection, USP Sterile Solution is available in the following packages:

1 mL single-dose vial NDC 83270-002-01

10 x 1 mL single-dose vials NDC 83270-002-02

Each mL of carboprost tromethamine injection contains carboprost tromethamine equivalent to 250 mcg of carboprost.

Carboprost tromethamine injection must be refrigerated at 2° to 8° C (36° to 46° F).

Discard unused portion.

Rx only

Manufactured For:

Steriscience Specialities Pte. Limited

Revised: September 2024

To report SUSPECTED ADVERSE REACTIONS, contact Steriscience at 1-888-278-1784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION

Carboprost tromethamine injection, USP Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in Carboprost tromethamine injection, USP. Four other chemical names are:
1. (15S)-15-methyl prostaglandin F2α tromethamine salt
2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt
4. (15S)-15-methyl PGF2α-THAM
The structural formula is represented below:


The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating.

Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL.
Each mL of carboprost tromethamine injection, USP Sterile Solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.