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  5. NDC Package Code: 64850-621-01 Oxycodone Hydrochloride And Acetaminophen

NDC Package 64850-621-01 Oxycodone Hydrochloride 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:
64850-621-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
64850-621
Proprietary Name:
Oxycodone Hydrochloride And Acetaminophen
Non-Proprietary Name:
Oxycodone Hydrochloride And Acetaminophen
Substance Name:
Acetaminophen; Oxycodone Hydrochloride
Usage Information:
Oxycodone and Acetaminophen Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone 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:
64850062101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1049214 - oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 1049214 - acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet
  • RxCUI: 1049214 - APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet
  • RxCUI: 1049221 - oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 1049221 - acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Elite Laboratories, 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):
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA209385
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
12-04-2017
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 64850-621-01?

The NDC Packaged Code 64850-621-01 is assigned to a package of 100 tablet in 1 bottle of Oxycodone Hydrochloride And Acetaminophen, a human prescription drug labeled by Elite Laboratories, Inc.. The product's dosage form is tablet and is administered via oral form.

Is NDC 64850-621 included in the NDC Directory?

Yes, Oxycodone Hydrochloride And Acetaminophen with product code 64850-621 is active and included in the NDC Directory. The product was first marketed by Elite Laboratories, Inc. on December 04, 2017 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 NDC billing unit for package 64850-621-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 64850-621-01?

The 11-digit format is 64850062101. 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
5-3-264850-621-015-4-264850-0621-01