Emtricitabine And Tenofovir Disoproxil Fumarate Tablet, Film Coated
NDC Package 76282-677-30
Package Information
Emtricitabine And Tenofovir Disoproxil Fumarate tablets is 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)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-677 and is authorized under FDA application ANDA090958.
Identification & Billing
- 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
Clinical Specifications
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor - [EPC] (Established Pharmacologic Class)
- Nucleoside Reverse Transcriptase Inhibitors - [MoA] (Mechanism of Action)
- Nucleosides - [CS]
Regulatory & Marketing
Hierarchy Structure
- 76282 - Exelan Pharmaceuticals, Inc.
- 76282-677 - Emtricitabine And Tenofovir Disoproxil Fumarate
- 76282-677-30 - 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- 76282-677 - Emtricitabine And Tenofovir Disoproxil Fumarate
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 full disclaimer at the bottom of this page.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 76282-677-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Emtricitabine And Tenofovir Disoproxil Fumarate, a human prescription drug labeled by Exelan Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains emtricitabine; tenofovir disoproxil fumarate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exelan Pharmaceuticals, Inc. on April 06, 2021. The current certification is valid through December 31, 2026.
How is this Exelan Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282067730. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
