NDC Package 49288-0575-4 Standardized Timothy Grass Pollen

View Billable Units, 11-Digit Format, RxNorm

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:

49288-0575-4

Package Description:

30 mL in 1 VIAL, MULTI-DOSE

Product Code:

49288-0575

Proprietary Name:

Standardized Timothy Grass Pollen

Usage Information:

INDICATIONS AND USAGE Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.

11-Digit NDC Billing Format:

49288057504

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:

Antigen Laboratories, Inc.

Sample Package:

Start Marketing Date:

06-13-1997

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

49288 - Antigen Laboratories, Inc.
- 49288-0575 - Standardized Timothy Grass Pollen
  - 49288-0575-4 - 30 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
49288-0575-2	5 mL in 1 VIAL, MULTI-DOSE
49288-0575-3	10 mL in 1 VIAL, MULTI-DOSE
49288-0575-5	50 mL in 1 VIAL, MULTI-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 49288-0575-4?

The NDC Packaged Code 49288-0575-4 is assigned to a package of 30 ml in 1 vial, multi-dose of Standardized Timothy Grass Pollen, labeled by Antigen Laboratories, Inc.. The product's dosage form is and is administered via form.

Is NDC 49288-0575 included in the NDC Directory?

No, Standardized Timothy Grass Pollen with product code 49288-0575 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Antigen Laboratories, Inc. on June 13, 1997 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 49288-0575-4?

The 11-digit format is 49288057504. 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 5-4-1 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
5-4-1	49288-0575-4	5-4-2	49288-0575-04

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