Antivenin
NDC Package 0006-4084-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Antivenin is (Latrodectus mactans) is used to treat patients with symptoms due to bites by the black widow spider (Latrodectus mactans). Marketed by Merck Sharp & Dohme Corp., this product is identified by NDC 0006-4084 and is authorized under FDA application BLA101062.

Identification & Billing

NDC Package Code
0006-4084-00
Package Description
1 KIT in 1 CARTON * 1 mL in 1 VIAL (0006-9011-00) * 2.5 mL in 1 VIAL (0006-9002-00) * 2.5 mL in 1 VIAL
Product Code
0006-4084
11-Digit Billing Format
00006408400
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Antivenin
Dosage Form
-
Usage Information
Antivenin (Latrodectus mactans) is used to treat patients with symptoms due to bites by the black widow spider (Latrodectus mactans). Early use of the Antivenin is emphasized for prompt relief.Local muscular cramps begin from 15 minutes to several hours after the bite which usually produces a sharp pain similar to that caused by puncture with a needle. The exact sequence of symptoms depends somewhat on the location of the bite. The venom acts on the myoneural junctions or on the nerve endings, causing an ascending motor paralysis or destruction of the peripheral nerve endings. The groups of muscles most frequently affected at first are those of the thigh, shoulder, and back. After a varying length of time, the pain becomes more severe, spreading to the abdomen, and weakness and tremor usually develop. The abdominal muscles assume a boardlike rigidity, but tenderness is slight. Respiration is thoracic. The patient is restless and anxious. Feeble pulse, cold, clammy skin, labored breathing and speech, light stupor, and delirium may occur. Convulsions also may occur, particularly in small children. The temperature may be normal or slightly elevated. Urinary retention, shock, cyanosis, nausea and vomiting, insomnia, and cold sweats also have been reported. The syndrome following the bite of the black widow spider may be confused easily with any medical or surgical condition with acute abdominal symptoms.The symptoms of black widow spider bite increase in severity for several hours, perhaps a day, and then very slowly become less severe, gradually passing off in the course of two or three days except in fatal cases. Residual symptoms such as general weakness, tingling, nervousness, and transient muscle spasm may persist for weeks or months after recovery from the acute stage.If possible, the patient should be hospitalized. Other additional measures giving greatest relief are prolonged warm baths and intravenous injection of 10 mL of 10 percent solution of calcium gluconate repeated as necessary to control muscle pain. Morphine also may be required to control pain. Barbiturates may be used for extreme restlessness. However, as the venom is a neurotoxin, it can cause respiratory paralysis. This must be borne in mind when considering use of morphine or a barbiturate. Adrenocorticosteroids have been used with varying degrees of success. Supportive therapy is indicated by the condition of the patient. Local treatment of the site of the bite is of no value. Nothing is gained by applying a tourniquet or by attempting to remove venom from the site of the bite by incision and suction.In otherwise healthy individuals between the ages of 16 and 60, the use of Antivenin may be deferred and treatment with muscle relaxants may be considered.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Corp.
FDA Application #
BLA101062
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-14-1947
End Marketing Date
03-27-2015
Listing Expiration
03-27-2015
Exclude Flag
D
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0006-4084-00 identifies a specific commercial package of 1 kit in 1 carton * 1 ml in 1 vial (0006-9011-00) * 2.5 ml in 1 vial (0006-9002-00) * 2.5 ml in 1 vial of Antivenin, labeled by Merck Sharp & Dohme Corp.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Merck Sharp & Dohme Corp. on May 14, 1947. The current certification is valid through March 27, 2015.

How is this Merck Sharp & Dohme Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006408400. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 (4-4-2)
0006-4084-00
11-Digit CMS (5-4-2)
00006-4084-00

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