70644-215 NDC - FORMOTEROL FUMARATE INHALATION SOLUTION AND PARI LC PLUS NEBULIZER

Drug Information

  • Product NDC: 70644-215
  • Proprietary Name: Formoterol Fumarate Inhalation Solution and PARI LC PLUS Nebulizer
  • Non Proprietary Name: Formoterol Fumarate Inhalation Solution and PARI LC PLUS Nebulizer
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s): KIT

Labeler Information

Field Name Field Value
Labeler Name: Genericus, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA215883
Marketing Category: ANDA
Start Marketing Date:9/16/2024

Package Information

No. Package Code Package Description Billing Unit
170644-215-301 KIT in 1 PACKAGE (70644-215-30) * 60 VIAL in 1 CARTON / 2 mL in 1 VIAL * 30 VIAL in 1 CARTON / 2 mL in 1 VIAL * 1 in 1 PACKAGEML
270644-215-601 KIT in 1 PACKAGE (70644-215-60) * 60 VIAL in 1 CARTON / 2 mL in 1 VIAL * 30 VIAL in 1 CARTON / 2 mL in 1 VIAL * 1 in 1 PACKAGEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC70644-215The 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 NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEFormoterol Fumarate Inhalation Solution and PARI LC PLUS NebulizerThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEFormoterol Fumarate Inhalation Solution and PARI LC PLUS NebulizerThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEKITThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE9/16/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA215883This 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 NAMEGenericus, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 4/4/2025

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