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  5. NDC Package Code: 64380-440-01 Hydrocodone Bitartrate And Acetaminophen

NDC Package 64380-440-01 Hydrocodone Bitartrate And Acetaminophen

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

Table of Contents

    1. Package Information
    2. 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:
64380-440-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
64380-440
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, which can occur at any dosage or duration [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 analgesiaHydrocodone Bitartrate and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
11-Digit NDC Billing Format:
64380044001
Product Type:
Human Prescription Drug
Labeler Name:
Strides Pharma Science Limited
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):
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA202935
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-01-2025
Listing Expiration Date:
12-31-2026
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.

Frequently Asked Questions

What is NDC 64380-440-01?

The NDC Packaged Code 64380-440-01 is assigned to a package of 100 tablet in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Strides Pharma Science Limited. The product's dosage form is tablet and is administered via oral form.

Is NDC 64380-440 included in the NDC Directory?

Yes, Hydrocodone Bitartrate And Acetaminophen with product code 64380-440 is active and included in the NDC Directory. The product was first marketed by Strides Pharma Science Limited on July 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64380-440-01?

The 11-digit format is 64380044001. 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
5-3-264380-440-015-4-264380-0440-01