59617-0015 NDC - ORALAIR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN)

Drug Information

Product NDC: 59617-0015
Proprietary Name: Oralair
Non Proprietary Name: ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
Active Ingredient(s): 300 [IR]/1 ANTHOXANTHUM ODORATUM POLLEN; 300 [IR]/1 DACTYLIS GLOMERATA POLLEN; 300 [IR]/1 LOLIUM PERENNE POLLEN; 300 [IR]/1 PHLEUM PRATENSE POLLEN; 300 [IR]/1 POA PRATENSIS POLLEN
Administration Route(s): SUBLINGUAL
Dosage Form(s): TABLET, ORALLY DISINTEGRATING
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Standardized Pollen Allergenic Extract [EPC]; Standardized Pollen Allergenic Extract [EPC]; Standardized Pollen Allergenic Extract [EPC]; Standardized Pollen Allergenic Extract [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Stallergenes
Product Type:	STANDARDIZED ALLERGENIC
FDA Application Number:	BLA125471
Marketing Category:	BLA
Start Marketing Date:	4/30/2014

Package Information

No.	Package Code	Package Description	Billing Unit
1	59617-0015-2	30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59617-0015-2)	EA
2	59617-0015-3	1 BLISTER PACK in 1 BOX (59617-0015-3) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	59617-0015	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	STANDARDIZED ALLERGENIC	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.
PROPRIETARY NAME	Oralair	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX	300 IR	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAME	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, ORALLY DISINTEGRATING	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	SUBLINGUAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	4/30/2014	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	BLA	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBER	BLA125471	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.
LABELER NAME	Stallergenes	The translation of the route code submitted by the firm, indicating route of administration.
SUBSTANCE NAME	ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN	This is the date that the labeler indicates was the start of its marketing of the drug product.
ACTIVE NUMERATOR STRENGTH	300; 300; 300; 300; 300	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.
ACTIVE INGRED UNIT	[IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1
PHARM CLASSES	Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]

59617-0015 NDC - ORALAIR (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, AND POA PRATENSIS POLLEN)

Drug Information

Labeler Information

Package Information

NDC Record

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