Oyster
NDC Package 36987-1237-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Oyster is allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Marketed by Nelco Laboratories, Inc., this product is identified by NDC 36987-1237 and is authorized under FDA application BLA102192.

Identification & Billing

NDC Package Code
36987-1237-2
Package Description
10 mL in 1 VIAL, MULTI-DOSE
Product Code
36987-1237
11-Digit Billing Format
36987123702
RxNorm Crosswalk
  • RxCUI: 892506 - tuna allergenic extract 100 MG/ML Injectable Solution
  • RxCUI: 892506 - tuna allergenic extract 0.1 GM/ML Injectable Solution
  • RxCUI: 892542 - clam allergenic extract 100 MG/ML Injectable Solution
  • RxCUI: 892542 - quahog allergenic extract 0.1 GM/ML Injectable Solution
  • RxCUI: 892546 - codfish allergenic extract 100 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Oyster
Dosage Form
-
Usage Information
Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.

Regulatory & Marketing

Labeler Name
Nelco Laboratories, Inc.
FDA Application #
BLA102192
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-29-1972
Listing Expiration
12-31-2017
Exclude Flag
I
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 (36987-1237). Click a package code to view its specific billing and regulatory data.

36987-1237-1
5 mL in 1 VIAL, MULTI-DOSE
36987-1237-3
30 mL in 1 VIAL, MULTI-DOSE
36987-1237-4
50 mL in 1 VIAL, MULTI-DOSE

* 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 36987-1237-2 identifies a specific commercial package of 10 ml in 1 vial, multi-dose of Oyster, labeled by Nelco Laboratories, Inc.. 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 Nelco Laboratories, Inc. on August 29, 1972. The current certification is valid through December 31, 2017.

How is this Nelco Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36987123702. 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 (5-4-1)
36987-1237-2
11-Digit CMS (5-4-2)
36987-1237-02

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