Temozolomide Capsule
NDC Package 70301-2011-1

11-digit billing NDC: 70301201101 · Billing unit: EA · 5 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Temozolomide capsules is temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: • temozolomide or any other ingredients in Temozolomide capsules; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. This formulation utilizes a capsule delivery system. Marketed by Opko Pharmaceuticals, Llc, this product is identified by NDC 70301-2011 and is authorized under FDA application ANDA203898.

Identification & Billing

NDC Package Code
70301-2011-1
Package Description
5 PACKET in 1 CARTON / 1 CAPSULE in 1 PACKET
Product Code
70301-2011
11-Digit Billing Format
70301201101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk
RxCUI: 313210 - temozolomide 250 MG Oral Capsule

Clinical Specifications

Proprietary Name
Temozolomide
Non-Proprietary Name
Temozolomide
Substance Name
Temozolomide
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)
TEMOZOLOMIDE 250 mg/1
Pharmacologic Class
Usage Information
Temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: • temozolomide or any other ingredients in Temozolomide capsules; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to Temozolomide have included anaphylaxis [see Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Opko Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203898
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-16-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70301-2011-1 identifies a specific commercial package of 5 packet in 1 carton / 1 capsule in 1 packet of Temozolomide, a human prescription drug labeled by Opko Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package. This capsule is formulated for oral use and contains temozolomide 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 Opko Pharmaceuticals, Llc on September 16, 2026. The current certification is valid through December 31, 2027.

How is this Opko Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70301201101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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:

10-Digit Format (5-4-1)
70301-2011-1
11-Digit CMS (5-4-2)
70301-2011-01

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