NDC Package 70710-1364-3 Emtricitabine And Tenofovir Disoproxil Fumarate

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

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:
70710-1364-3
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Emtricitabine And Tenofovir Disoproxil Fumarate
Non-Proprietary Name:
Emtricitabine And Tenofovir Disoproxil Fumarate
Substance Name:
Emtricitabine; Tenofovir Disoproxil Fumarate
Usage Information:
Emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)].
11-Digit NDC Billing Format:
70710136403
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1744001 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet
  • RxCUI: 1744001 - emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet
  • RxCUI: 1744005 - emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet
  • RxCUI: 1744005 - emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral Tablet
  • RxCUI: 1744009 - emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Zydus Pharmaceuticals Usa Inc.
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
ANDA212689
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-01-2021
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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 70710-1364-3 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
70710136403J0750EMTRICITABINE 200MG AND TENOFOVIR DISOPROXIL FUMARATE 300MG, ORAL, FDA APPROVED PRESCRIPTION, ONLY FOR USE AS HIV PRE-EXPOSURE PROPHYLAXIS (NOT FOR USE AS TREATMENT OF HIV)200 MG30EA

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
70710-1364-410 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1364-2)
70710-1364-990 TABLET, FILM COATED in 1 BOTTLE

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Frequently Asked Questions

What is NDC 70710-1364-3?

The NDC Packaged Code 70710-1364-3 is assigned to a package of 30 tablet, film coated in 1 bottle of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 70710-1364 included in the NDC Directory?

Yes, Emtricitabine And Tenofovir Disoproxil Fumarate with product code 70710-1364 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on July 01, 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 NDC billing unit for package 70710-1364-3?

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 30.

What is the 11-digit format for NDC 70710-1364-3?

The 11-digit format is 70710136403. 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 5-4-1 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
5-4-170710-1364-35-4-270710-1364-03