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  4. NDC Product Code: 12634-978 Hydrocodone Bitartrate And Acetaminophen

NDC 12634-978 Hydrocodone Bitartrate And Acetaminophen

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 12634-978?
  5. Hydrocodone Bitartrate And Acetaminophen Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
12634-978
Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Product Type: [3]
Labeler Name: [5]
Apotheca, Inc.
Labeler Code:
12634
Product Label ID:
fcb16b75-fd8a-4b68-b5e2-8fa9f0b0f88e
FDA Application Number: [6]
ANDA040148
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
07-01-2008
End Marketing Date: [10]
12-31-2014
Listing Expiration Date: [11]
12-31-2014
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE-TO OFF WHITE)
BLUE (C48333 - BLUE)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
IP;110
WATSON;540
Score:
2

Code Structure Chart

Product Details

What is NDC 12634-978?

The NDC code 12634-978 is assigned by the FDA to the product Hydrocodone Bitartrate And Acetaminophen which is product labeled by Apotheca, Inc.. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 12634-978-00 10 tablet in 1 bottle, plastic , 12634-978-55 15 tablet in 1 blister pack , 12634-978-71 30 tablet in 1 bottle, plastic , 12634-978-85 15 tablet in 1 bottle, plastic , 12634-978-91 1 tablet in 1 blister pack , 12634-978-95 5 tablet in 1 bottle, plastic . 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 Bitartrate And Acetaminophen?

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

Which are Hydrocodone Bitartrate And Acetaminophen UNII Codes?

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

Which are Hydrocodone Bitartrate And Acetaminophen 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 Bitartrate And Acetaminophen?

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: 856999 - HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 856999 - acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet
  • RxCUI: 856999 - APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet
  • RxCUI: 857107 - HYDROcodone bitartrate 10 MG / acetaminophen 500 MG Oral Tablet
  • RxCUI: 857107 - acetaminophen 500 MG / hydrocodone bitartrate 10 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.

[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".