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  4. NDC Product Code: 0069-0277 Doxorubicin Hydrochloride

NDC 0069-0277 Doxorubicin Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0069-0277?
  4. Doxorubicin Hydrochloride Uses
  5. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
0069-0277
Proprietary Name:
Doxorubicin Hydrochloride
Product Type: [3]
Labeler Name: [5]
Pfizer Laboratories Div Pfizer Inc
Labeler Code:
0069
Product Label ID:
1fd148fb-0fbc-4b6f-b790-23546fb46a71
FDA Application Number: [6]
NDA050629
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-09-2024
End Marketing Date: [10]
05-09-2024
Listing Expiration Date: [11]
05-09-2024
Exclude Flag: [12]
D
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Product Details

What is NDC 0069-0277?

The NDC code 0069-0277 is assigned by the FDA to the product Doxorubicin Hydrochloride which is product labeled by Pfizer Laboratories Div Pfizer Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0069-0277-02 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose. 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 Doxorubicin Hydrochloride?

Doxorubicin Hydrochloride Injection/for Injection are contraindicated in patients with:Severe myocardial insufficiency [see Warnings and Precautions (5.1)]Recent (occurring within the past 4–6 weeks) myocardial infarction [see Warnings and Precautions (5.1)]Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4)]Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5)]Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2)]

What is the NDC to RxNorm Crosswalk for Doxorubicin 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:

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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.

[10] What is the End Marketing Date? - 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.

[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".