Beclomethasone Dipropionate Aerosol, Metered
NDC 69238-1289

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 69238-1289?
  4. Beclomethasone Dipropionate Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Beclomethasone Dipropionate is a ANDA-approved product labeled by Amneal Pharmaceuticals Ny Llc. Beclomethasone is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). It is supplied as a aerosol, metered for respiratory (inhalation) administration. This product entry covers the primary NDC 69238-1289 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
69238-1289
Proprietary Name:
Beclomethasone Dipropionate
Non-Proprietary Name: [1]
Beclomethasone Dipropionate
Substance Name: [2]
Beclomethasone Dipropionate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Aerosol, Metered - A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation.
Administration Route(s): [4]
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Labeler & Regulatory Data

Labeler Name: [5]
Amneal Pharmaceuticals Ny Llc
Labeler Code:
69238
Product Label ID:
d853c96f-21a3-4def-931d-4d47d16acd62
FDA Application Number: [6]
ANDA213811
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-17-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 69238-1289?

The NDC code 69238-1289 is assigned by the FDA to the product Beclomethasone Dipropionate. This pharmaceutical product is labeled by Amneal Pharmaceuticals Ny Llc and is currently categorized as listed product. The medication is a aerosol, metered administered via respiratory (inhalation) route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 69238-1289-4. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Beclomethasone is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). It may be used to treat symptoms (such as stuffy/runny nose) caused by other triggers (such as cigarette smoke, perfumes). It is also used to prevent the return of growths in the nose (nasal polyps) after removal by surgery. Beclomethasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 1490666 - beclomethasone dipropionate 80 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1490666 - 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler
  • RxCUI: 1490666 - beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler, 120 ACTUATS
  • RxCUI: 1490773 - beclomethasone dipropionate 40 MCG/INHAL Metered Dose Inhaler, 120 Actuations
  • RxCUI: 1490773 - 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".