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  5. NDC Package Code: 0904-3854-61 Carbamazepine

NDC Package 0904-3854-61 Carbamazepine

Tablet, Chewable Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0904-3854-61
Package Description:
100 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code:
0904-3854
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:
00904385461
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 308973 - carBAMazepine 100 MG Chewable Tablet
  • RxCUI: 308973 - carbamazepine 100 MG Chewable Tablet
  • RxCUI: 308979 - carBAMazepine 200 MG Oral Tablet
  • RxCUI: 308979 - carbamazepine 200 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Major Pharmaceuticals
    Dosage Form:
    Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CARBAMAZEPINE 100 mg/1
    • 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:
    ANDA075712
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-22-2010
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0904-3854-801000 TABLET, CHEWABLE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0904-3854-61?

    The NDC Packaged Code 0904-3854-61 is assigned to a package of 100 blister pack in 1 carton / 1 tablet, chewable in 1 blister pack of Carbamazepine, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is tablet, chewable and is administered via oral form.

    Is NDC 0904-3854 included in the NDC Directory?

    Yes, Carbamazepine with product code 0904-3854 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on March 22, 2010 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 0904-3854-61?

    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 100.

    What is the 11-digit format for NDC 0904-3854-61?

    The 11-digit format is 00904385461. 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
    4-4-20904-3854-615-4-200904-3854-61