temozolomide NDC 75834-142

NDC codes

FDA NDC Directory

Product NDC (as listed)75834-142Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75834-0142Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
75834-142-05	75834014205	1 BOTTLE in 1 CARTON (75834-142-05) / 5 CAPSULE in 1 BOTTLEMarketed from Dec 7, 2021
75834-142-14	75834014214	1 BOTTLE in 1 CARTON (75834-142-14) / 14 CAPSULE in 1 BOTTLEMarketed from Dec 7, 2021

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): temozolomide
Generic name (nonproprietary): temozolomide
Active ingredients: Temozolomide — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Nivagen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213328
Marketing start: Dec 7, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 75834-142_9db23336-458a-46a6-a676-1702497a1891SPL ID 9db23336-458a-46a6-a676-1702497a1891SPL set ID 27e5a781-e4f2-4489-9def-7971d0b86d9cRxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII YF1K15M17YUPC 0375834145051, 0375834144146, 0375834144054, 0375834143057, 0375834143149, 0375834145143, 0375834142142, 0375834142050, 0375834146058, 0375834132143, 0375834132051
Pharmacologic class: Alkylating Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N475834014205 followed by a unit qualifier and the quantity

Package 75834-0142-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 28, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Temozolomide capsules, USP is an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2) 1.1 Newly Diagnosed Glioblastoma Temozolomide capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma Temozolomide capsules, USP is indicated for the treatment of adult patients with refractory anaplastic as…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213328

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213328
Product	Strength	Form · route	Labeler	Product NDC
temozolomide	Temozolomide 5 mg/1	CapsuleOral	Nivagen Pharmaceuticals, Inc.	75834-132
temozolomide	Temozolomide 100 mg/1	CapsuleOral	Nivagen Pharmaceuticals, Inc.	75834-143
temozolomide	Temozolomide 140 mg/1	CapsuleOral	Nivagen Pharmaceuticals, Inc.	75834-144
temozolomide	Temozolomide 180 mg/1	CapsuleOral	Nivagen Pharmaceuticals, Inc.	75834-145
temozolomide	Temozolomide 250 mg/1	CapsuleOral	Nivagen Pharmaceuticals, Inc.	75834-146