70860-454 NDC - DESMOPRESSIN ACETATE ()

Drug Information

Field Name	Field Value
Labeler Name:	Athenex Pharmaceutical Division, LLC.
Product Type:
FDA Application Number:	ANDA210223
Marketing Category:	ANDA
Start Marketing Date:	11/30/2020
End Marketing Date:	10/31/2024

No.	Package Code	Package Description	Billing Unit
1	70860-454-01	10 VIAL in 1 CARTON (70860-454-01) / 1 mL in 1 VIAL (70860-454-41)	ML
2	70860-454-10	1 VIAL in 1 CARTON (70860-454-10) / 10 mL in 1 VIAL	ML

Field Name	Field Value	Definition
PRODUCT NDC	70860-454	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.
PROPRIETARY NAME	Desmopressin Acetate	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	11/30/2020	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
END MARKETING DATE	10/31/2024	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	ANDA	The translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBER	ANDA210223	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Athenex Pharmaceutical Division, LLC.	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.