NDC 54348-015 Acetaminophen With Codeine

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:
54348-015
Proprietary Name:
Acetaminophen With Codeine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
54348
Start Marketing Date: [9]
12-31-2013
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
2064;V;3
Score:
2

Code Structure Chart

Product Details

What is NDC 54348-015?

The NDC code 54348-015 is assigned by the FDA to the product Acetaminophen With Codeine which is product labeled by Pharmpak, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54348-015-01 1 blister pack in 1 box / 1 tablet in 1 blister pack. 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 With Codeine?

Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

Which are Acetaminophen With Codeine UNII Codes?

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

Which are Acetaminophen With Codeine 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 With Codeine?

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".