NDC 54348-066 Hydrocodone/apap

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:
54348-066
Proprietary Name:
Hydrocodone/apap
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Pharmpak, Inc.
Labeler Code:
54348
Start Marketing Date: [9]
09-01-2014
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
IP;109
Score:
2

Product Packages

NDC Code 54348-066-01

Package Description: 1 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK

NDC Code 54348-066-10

Package Description: 10 TABLET in 1 BOTTLE

Product Details

What is NDC 54348-066?

The NDC code 54348-066 is assigned by the FDA to the product Hydrocodone/apap which is product labeled by Pharmpak, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 54348-066-01 1 blister pack in 1 box / 1 tablet in 1 blister pack, 54348-066-10 10 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 Hydrocodone/apap?

Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain.

Which are Hydrocodone/apap UNII Codes?

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

Which are Hydrocodone/apap 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 Hydrocodone/apap?

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: 857002 - HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 857002 - acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet
  • RxCUI: 857002 - APAP 325 MG / hydrocodone bitartrate 5 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".