Carboprost Tromethamine Injection, Solution
NDC Package 42571-435-72

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Carboprost Tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:Failure of expulsion of the fetus during the course of treatment by another method;Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. This formulation utilizes a injection, solution delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-435 and is authorized under FDA application ANDA218013.

Identification & Billing

NDC Package Code
42571-435-72
Package Description
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (42571-435-54)
Product Code
42571-435
11-Digit Billing Format
42571043572
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carboprost Tromethamine
Non-Proprietary Name
Carboprost Tromethamine
Substance Name
Carboprost Tromethamine
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
CARBOPROST TROMETHAMINE 250 ug/mL
Pharmacologic Class
Usage Information
Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:Failure of expulsion of the fetus during the course of treatment by another method;Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.  Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218013
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42571-435-72 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial (42571-435-54) of Carboprost Tromethamine, a human prescription drug labeled by Micro Labs Limited. This injection, solution is formulated for intramuscular use and contains carboprost tromethamine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Micro Labs Limited on August 01, 2024. The current certification is valid through December 31, 2026.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571043572. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42571-435-72
11-Digit CMS (5-4-2)
42571-0435-72

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.