NDC 53217-370 Acetaminophen And Codeine Phosphate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
53217-370
Proprietary Name:
Acetaminophen And Codeine Phosphate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aidarex Pharmaceuticals Llc
Labeler Code:
53217
Start Marketing Date: [9]
04-03-2018
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - TO OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
3;M
Score:
1

Product Packages

NDC Code 53217-370-20

Package Description: 20 TABLET in 1 BOTTLE

Product Details

What is NDC 53217-370?

The NDC code 53217-370 is assigned by the FDA to the product Acetaminophen And Codeine Phosphate which is product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53217-370-20 20 tablet 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 Acetaminophen And Codeine Phosphate?

Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)Have not provided adequate analgesia, or are not expected to provide adequate analgesia,Have not been tolerated, or are not expected to be tolerated.

Which are Acetaminophen And Codeine Phosphate UNII Codes?

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

Which are Acetaminophen And Codeine Phosphate 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 Acetaminophen And Codeine Phosphate?

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: 993781 - codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 993781 - acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet
  • RxCUI: 993781 - APAP 300 MG / codeine phosphate 30 MG Oral Tablet

* 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.

[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".