NDC Package 0904-7172-07 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:
0904-7172-07
Package Description:
30 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
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:
00904717207
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: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
  • RxCUI: 476556 - emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Major Pharmaceuticals
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:
ANDA212114
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-26-2019
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.

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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 0904-7172-07 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00904717207J0750EMTRICITABINE 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

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0904-7172-07?

The NDC Packaged Code 0904-7172-07 is assigned to a package of 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 0904-7172 included in the NDC Directory?

Yes, Emtricitabine And Tenofovir Disoproxil Fumarate with product code 0904-7172 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on July 26, 2019 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 0904-7172-07?

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 0904-7172-07?

The 11-digit format is 00904717207. 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 4-4-2 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
4-4-20904-7172-075-4-200904-7172-07