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  4. NDC Product Code: 69238-1502 Phenoxybenzamine Hydrochloride

NDC 69238-1502 Phenoxybenzamine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69238-1502?
  5. Phenoxybenzamine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69238-1502
Proprietary Name:
Phenoxybenzamine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Amneal Pharmaceuticals Ny Llc
Labeler Code:
69238
Product Label ID:
1daacf09-355c-4e22-88b0-dcd1e18f13d2
FDA Application Number: [6]
ANDA212568
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-30-2020
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
RED (C48326 - RED CAP AND RED BODY)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
AMNEAL;1502
Score:
1

Code Structure Chart

Product Details

What is NDC 69238-1502?

The NDC code 69238-1502 is assigned by the FDA to the product Phenoxybenzamine Hydrochloride which is product labeled by Amneal Pharmaceuticals Ny Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69238-1502-1 100 capsule in 1 bottle . 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 Phenoxybenzamine Hydrochloride?

Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the phenoxybenzamine hydrochloride capsules,  or any of its components.

Which are Phenoxybenzamine Hydrochloride UNII Codes?

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

  • PHENOXYBENZAMINE HYDROCHLORIDE (UNII: X1IEG24OHL)
  • PHENOXYBENZAMINE (UNII: 0TTZ664R7Z) (Active Moiety)

Which are Phenoxybenzamine Hydrochloride 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 Phenoxybenzamine Hydrochloride?

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:

* 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.

[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".