1. Home
  2. Labeler Index
  3. Stelis Biopharma Limited
  4. 83270-002
  5. NDC Package Code: 83270-002-02 Carboprost Tromethamine

NDC Package 83270-002-02 Carboprost Tromethamine

Injection, Solution Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83270-002-02
Package Description:
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (83270-002-01)
Product Code:
83270-002
Proprietary Name:
Carboprost Tromethamine
Non-Proprietary Name:
Carboprost Tromethamine
Substance Name:
Carboprost Tromethamine
Usage Information:
Carboprost tromethamine injection Sterile Solution 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.
11-Digit NDC Billing Format:
83270000202
NDC to RxNorm Crosswalk:
  • RxCUI: 238014 - carboprost tromethamine 250 MCG in 1 ML Injection
  • RxCUI: 238014 - 1 ML carboprost 0.25 MG/ML Injection
  • RxCUI: 238014 - carboprost 250 MCG per 1 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Stelis Biopharma Limited
    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(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • CARBOPROST TROMETHAMINE 250 ug/mL
    • Pharmacologic Class(es):
  • Prostaglandin Analog - [EPC] (Established Pharmacologic Class)
  • Prostaglandins - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA216897
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 83270-002-02?

    The NDC Packaged Code 83270-002-02 is assigned to a package of 10 vial in 1 carton / 1 ml in 1 vial (83270-002-01) of Carboprost Tromethamine, a human prescription drug labeled by Stelis Biopharma Limited. The product's dosage form is injection, solution and is administered via intramuscular form.

    Is NDC 83270-002 included in the NDC Directory?

    Yes, Carboprost Tromethamine with product code 83270-002 is active and included in the NDC Directory. The product was first marketed by Stelis Biopharma Limited on November 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83270-002-02?

    The 11-digit format is 83270000202. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-283270-002-025-4-283270-0002-02