1. Home
  2. Labeler Index
  3. Alk-abello, Inc.
  4. NDC Product Code: 0268-0189 Center-al - Platanus Racemosa Pollen

NDC 0268-0189 Center-al - Platanus Racemosa Pollen

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0268-0189?
  4. Center-al - Platanus Racemosa Pollen Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0268-0189
Proprietary Name:
Center-al - Platanus Racemosa Pollen
Product Type: [3]
Labeler Name: [5]
Alk-abello, Inc.
Labeler Code:
0268
Product Label ID:
6c30d6b8-e1bb-4c87-84a0-05261f3609fa
FDA Application Number: [6]
BLA103753
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
01-15-1975
End Marketing Date: [10]
04-04-2017
Listing Expiration Date: [11]
04-04-2017
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 0268-0189?

The NDC code 0268-0189 is assigned by the FDA to the product Center-al - Platanus Racemosa Pollen which is product labeled by Alk-abello, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 0268-0189-10 10 ml in 1 vial, multi-dose , 0268-0189-10 10 ml in 1 vial, multi-dose , 0268-0189-30 30 ml in 1 vial, multi-dose . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Center-al - Platanus Racemosa Pollen?

Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.

Which are Center-al - Platanus Racemosa Pollen UNII Codes?

The UNII codes for the active ingredients in this product are:

  • AGROSTIS GIGANTEA TOP (UNII: A5ODF78EPD)
  • AGROSTIS GIGANTEA TOP (UNII: A5ODF78EPD) (Active Moiety)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (Active Moiety)
  • LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0)
  • LOLIUM PERENNE POLLEN (UNII: 4T81LB52R0) (Active Moiety)
  • ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD)
  • ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (Active Moiety)
  • ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O)
  • ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (Active Moiety)
  • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK)
  • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (Active Moiety)
  • PLATANUS RACEMOSA POLLEN (UNII: BWC8DYU8OS)
  • PLATANUS RACEMOSA POLLEN (UNII: BWC8DYU8OS) (Active Moiety)

Which are Center-al - Platanus Racemosa Pollen Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Center-al - Platanus Racemosa Pollen?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1191181 - redtop grass pollen extract 20000 UNT/ML Injectable Suspension
  • RxCUI: 1191181 - Agrostis gigantea pollen extract 20,000 UNT/ML Injectable Suspension
  • RxCUI: 2560522 - black willow pollen extract 10000 UNT/mL Injectable Suspension
  • RxCUI: 2560522 - black willow pollen extract 10000 UNT/ML Injectable Suspension
  • RxCUI: 2560522 - Salix nigra pollen extract 10,000 UNT/ML Injectable Suspension

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".