Carbamazepine Tablet, Film Coated, Extended Release
NDC Package 62332-421-91

11-digit billing NDC: 62332042191
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Carbamazepine tablets is epilepsy Carbamazepine extended-release tablet is indicated for use as an anticonvulsant drug. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-421 and is authorized under FDA application ANDA219939.

Identification & Billing

NDC Package Code
62332-421-91
Package Description
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
62332-421
11-Digit Billing Format
62332042191
RxNorm Crosswalk
  • RxCUI: 199378 - carBAMazepine 100 MG 12HR Extended Release Oral Tablet
  • RxCUI: 199378 - 12 HR carbamazepine 100 MG Extended Release Oral Tablet
  • RxCUI: 199378 - carbamazepine 100 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 402505 - carBAMazepine 200 MG 12HR Extended Release Oral Tablet
  • RxCUI: 402505 - 12 HR carbamazepine 200 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Carbamazepine
Non-Proprietary Name
Carbamazepine
Substance Name
Carbamazepine
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBAMAZEPINE 200 mg/1
Pharmacologic Class
Usage Information
Epilepsy Carbamazepine extended-release tablet is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablet as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine extended-release tablets (see PRECAUTIONS, General). Trigeminal NeuralgiaCarbamazepine extended-release tablet is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. 

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219939
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2025
Listing Expiration
12-31-2027
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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62332-421). Click a package code to view its specific billing and regulatory data.

62332-421-31
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62332-421-91 identifies a specific commercial package of 1000 tablet, film coated, extended release in 1 bottle of Carbamazepine, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. This tablet, film coated, extended release is formulated for oral use and contains carbamazepine 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 Alembic Pharmaceuticals Inc. on July 26, 2025. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332042191. 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)
62332-421-91
11-Digit CMS (5-4-2)
62332-0421-91

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