NDC Package 49643-309-50 Standardized Redtop Grass

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Package Information
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Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

49643-309-50

Package Description:

50 mL in 1 VIAL, MULTI-DOSE

Product Code:

49643-309

Proprietary Name:

Standardized Redtop Grass

Usage Information:

Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. If these tests are negative, they may be repeated by the puncture method with 100,000 BAU/mL extract, or by the intradermal method using an appropriate dilution (see DOSAGE AND ADMINISTRATION). The extract also is indicated for use in the treatment of allergic symptoms by immunotherapy in patients with a history of grass pollen allergy and established sensitivity to grass pollen extract by skin testing. The availability of 10,000 and 100,000 BAU/mL extracts facilitates dose selection for safe switching to standardized grass pollen extracts. Previously untreated patients should be initially treated with appropriately diluted 10,000 BAU/mL. If tolerated, higher doses may be indicated. The use of grass pollen extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook13. Allermed's standardized grass pollen extracts labeled in BAU/mL are not interchangeable with alum-precipitated grass pollen extracts, grass pollen extracts labeled in AU/mL or non-standardized grass pollen extracts.

11-Digit NDC Billing Format:

49643030950

NDC to RxNorm Crosswalk:

RxCUI: 851873 - redtop grass pollen extract 100000 BAU/ML Injectable Solution

RxCUI: 851873 - Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution

RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/mL Injectable Solution

RxCUI: 852157 - Timothy grass pollen extract 100000 BAU/ML Injectable Solution

RxCUI: 852157 - Phleum pratense grass pollen extract 100,000 BAU/ML Injectable Solution

Labeler Name:

Allermed Laboratories, Inc.

Sample Package:

Start Marketing Date:

12-02-1996

Listing Expiration Date:

12-31-2022

Exclude Flag:

Code Structure:

49643 - Allermed Laboratories, Inc.
- 49643-309 - Standardized Redtop Grass
  - 49643-309-50 - 50 mL in 1 VIAL, MULTI-DOSE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
49643-309-05	5 mL in 1 VIAL, MULTI-DOSE
49643-309-10	10 mL in 1 VIAL, MULTI-DOSE
49643-309-30	30 mL in 1 VIAL, MULTI-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 49643-309-50?

The NDC Packaged Code 49643-309-50 is assigned to a package of 50 ml in 1 vial, multi-dose of Standardized Redtop Grass, labeled by Allermed Laboratories, Inc.. The product's dosage form is and is administered via form.

Is NDC 49643-309 included in the NDC Directory?

No, Standardized Redtop Grass with product code 49643-309 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Allermed Laboratories, Inc. on December 02, 1996 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 49643-309-50?

The 11-digit format is 49643030950. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	49643-309-50	5-4-2	49643-0309-50

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