Sumatriptan Succinate Injection
NDC Package 46708-657-01

11-digit billing NDC: 46708065701
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Sumatriptan Succinate injection is sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. This formulation utilizes a injection delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-657 and is authorized under FDA application ANDA213518.

Identification & Billing

NDC Package Code
46708-657-01
Package Description
2 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE
Product Code
46708-657
11-Digit Billing Format
46708065701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sumatriptan Succinate
Non-Proprietary Name
Sumatriptan Succinate
Substance Name
Sumatriptan Succinate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SUMATRIPTAN SUCCINATE 6 mg/.5mL
Pharmacologic Class
Usage Information
Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks.Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213518
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-06-2025
Listing Expiration
12-31-2026
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 (46708-657). Click a package code to view its specific billing and regulatory data.

46708-657-05
1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE

* 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 46708-657-01 identifies a specific commercial package of 2 syringe in 1 carton / .5 ml in 1 syringe of Sumatriptan Succinate, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This injection is formulated for subcutaneous use and contains sumatriptan succinate 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 Limited on November 06, 2025. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708065701. 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)
46708-657-01
11-Digit CMS (5-4-2)
46708-0657-01

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