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  5. NDC Package Code: 0904-7116-01 Carbamazepine

NDC Package 0904-7116-01 Carbamazepine

Suspension Oral - 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:
0904-7116-01
Package Description:
30 CUP in 1 CASE / 10 mL in 1 CUP (0904-7116-66)
Product Code:
0904-7116
Proprietary Name:
Carbamazepine
Non-Proprietary Name:
Carbamazepine
Substance Name:
Carbamazepine
Usage Information:
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity.
11-Digit NDC Billing Format:
00904711601
NDC to RxNorm Crosswalk:
  • RxCUI: 308976 - carBAMazepine 100 MG in 5 mL Oral Suspension
  • RxCUI: 308976 - carbamazepine 20 MG/ML Oral Suspension
  • RxCUI: 308976 - carbamazepine 100 MG per 5 ML Oral Suspension
  • RxCUI: 308976 - carbamazepine 200 MG per 10 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Major Pharmaceuticals
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CARBAMAZEPINE 100 mg/5mL
    • Pharmacologic Class(es):
  • Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
  • Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
  • Mood Stabilizer - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076729
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-20-2004
    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 0904-7116-01?

    The NDC Packaged Code 0904-7116-01 is assigned to a package of 30 cup in 1 case / 10 ml in 1 cup (0904-7116-66) of Carbamazepine, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is suspension and is administered via oral form.

    Is NDC 0904-7116 included in the NDC Directory?

    Yes, Carbamazepine with product code 0904-7116 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on September 20, 2004 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 0904-7116-01?

    The 11-digit format is 00904711601. 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 4-4-2 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
    4-4-20904-7116-015-4-200904-7116-01