1. Home
  2. Labeler Index
  3. Granules Pharmaceuticals Inc.
  4. 70010-674
  5. NDC Package Code: 70010-674-05 Hydrocodone Bitartrate And Acetaminophen

NDC Package 70010-674-05 Hydrocodone Bitartrate And Acetaminophen

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70010-674-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
70010-674
Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Substance Name:
Acetaminophen; Hydrocodone Bitartrate
Usage Information:
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • have not been tolerated, or are not expected to be tolerated • have not provided adequate analgesia, or are not expected to provide adequate analgesia
11-Digit NDC Billing Format:
70010067405
NDC to RxNorm Crosswalk:
  • 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: 857002 - HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 857002 - acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Granules Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/1
  • HYDROCODONE BITARTRATE 10 mg/1
    • Pharmacologic Class(es):
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA211729
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-18-2021
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70010-674-01100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70010-674-05?

    The NDC Packaged Code 70010-674-05 is assigned to a package of 500 tablet in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Granules Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 70010-674 included in the NDC Directory?

    Yes, Hydrocodone Bitartrate And Acetaminophen with product code 70010-674 is active and included in the NDC Directory. The product was first marketed by Granules Pharmaceuticals Inc. on August 18, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70010-674-05?

    The 11-digit format is 70010067405. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270010-674-055-4-270010-0674-05