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  5. NDC Package Code: 63629-2351-1 Tri-lo- Estarylla

NDC Package 63629-2351-1 Tri-lo- Estarylla

Norgestimate And Ethinyl Estradiol Kit - 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:
63629-2351-1
Package Description:
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code:
63629-2351
Proprietary Name:
Tri-lo- Estarylla
Non-Proprietary Name:
Norgestimate And Ethinyl Estradiol
Usage Information:
Do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions:•A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:•Smoke, if over age 35 [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)]•Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS (5.1)]•Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS (5.1)]•Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS (5.1)]•Have coronary artery disease [see WARNINGS AND PRECAUTIONS (5.1)]•Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS AND PRECAUTIONS (5.1)]•Have uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.4)]•Have diabetes mellitus with vascular disease [see WARNINGS AND PRECAUTIONS (5.6)]•Have headaches with focal neurological symptoms or migraine headaches with aura [see WARNINGS AND PRECAUTIONS (5.7)]▪Women over age 35 with any migraine headaches [see WARNINGS AND PRECAUTIONS (5.7)]•Liver tumors, benign or malignant, or liver disease [see WARNINGS AND PRECAUTIONS (5.2)]•Undiagnosed abnormal uterine bleeding [see WARNINGS AND PRECAUTIONS (5.8)]•Pregnancy, because there is no reason to use COCs during pregnancy [see WARNINGS AND PRECAUTIONS (5.9) and USE IN SPECIFIC POPULATIONS (8.1)]•Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see WARNINGS AND PRECAUTIONS (5.11)]•Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see WARNINGS AND PRECAUTIONS (5.3)]
11-Digit NDC Billing Format:
63629235101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1722676 - {7 (ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.025 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Tri-Lo- Estarylla 28 Day]
  • RxCUI: 1722676 - Tri-Lo- Estarylla 28 Day Pack
  • RxCUI: 578732 - norgestimate 0.18 MG / ethinyl estradiol 0.025 MG Oral Tablet
  • RxCUI: 578732 - ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet
  • RxCUI: 578732 - ethinyl estradiol 25 MCG / norgestimate 180 MCG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA091232
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-01-2018
    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 63629-2351-1?

    The NDC Packaged Code 63629-2351-1 is assigned to a package of 3 blister pack in 1 carton / 1 kit in 1 blister pack of Tri-lo- Estarylla, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is kit and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package.

    Is NDC 63629-2351 included in the NDC Directory?

    Yes, Tri-lo- Estarylla with product code 63629-2351 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on January 01, 2018 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 NDC billing unit for package 63629-2351-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 63629-2351-1?

    The 11-digit format is 63629235101. 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 5-4-1 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
    5-4-163629-2351-15-4-263629-2351-01