Sumatriptan Succinate Injection
NDC Package 71205-111-01

11-digit billing NDC: 71205011101 · Billing unit: ML · 1 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sumatriptan Succinate injection is sumatriptan injection, USP 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 Proficient Rx Lp, this product is identified by NDC 71205-111 and is authorized under FDA application ANDA078593.

Identification & Billing

NDC Package Code
71205-111-01
Package Description
1 mL in 1 VIAL
Product Code
71205-111
11-Digit Billing Format
71205011101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML
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, USP 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, USP, reconsider the diagnosis before sumatriptan injection, USP is administered to treat any subsequent attacks.•Sumatriptan injection, USP is not indicated for the prevention of migraine or cluster headache attacks.

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA078593
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-06-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71205-111-01 identifies a specific commercial package of 1 ml in 1 vial of Sumatriptan Succinate, a human prescription drug labeled by Proficient Rx Lp. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. 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 Proficient Rx Lp on February 06, 2009. The current certification is valid through December 31, 2027.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71205011101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 total billable units per package. 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)
71205-111-01
11-Digit CMS (5-4-2)
71205-0111-01

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