Oseltamivir Capsule
NDC Package 42385-985-01

11-digit billing NDC: 42385098501
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Oseltamivir (oseltamivir phosphate) capsules is oseltamivir phosphate is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. This formulation utilizes a capsule delivery system. Marketed by Laurus Labs Limited, this product is identified by NDC 42385-985 and is authorized under FDA application ANDA218565.

Identification & Billing

NDC Package Code
42385-985-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
42385-985
11-Digit Billing Format
42385098501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oseltamivir
Non-Proprietary Name
Oseltamivir Phosphate
Substance Name
Oseltamivir Phosphate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OSELTAMIVIR PHOSPHATE 30 mg/1
Pharmacologic Class
Usage Information
Oseltamivir phosphate is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens‐Johnson Syndrome, and erythema multiforme [see Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Laurus Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218565
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-02-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42385-985). Click a package code to view its specific billing and regulatory data.

42385-985-11
1 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (42385-985-10)

* 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 42385-985-01 identifies a specific commercial package of 100 capsule in 1 bottle of Oseltamivir, a human prescription drug labeled by Laurus Labs Limited. This capsule is formulated for oral use and contains oseltamivir phosphate 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 Laurus Labs Limited on May 02, 2024. The current certification is valid through December 31, 2027.

How is this Laurus Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42385098501. 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:

10-Digit Format (5-3-2)
42385-985-01
11-Digit CMS (5-4-2)
42385-0985-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.