Temozolomide NDC 16729-048

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-048Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0048Add 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
16729-048-53	16729004853	1 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASSMarketed from Mar 7, 2017
16729-048-54	16729004854	1 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASSMarketed from Mar 7, 2017

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 — 5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201528
Marketing start: Mar 7, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 16729-048_35ce99f0-8af9-4660-e063-6294a90a54bfSPL ID 35ce99f0-8af9-4660-e063-6294a90a54bfSPL set ID 2d599ccf-8e63-4ff1-aa52-4809744ea97aRxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII YF1K15M17YUPC 0316729051316, 0319729048317, 0316729050319, 0316729049535, 0316729129534, 0316729130318, 0316729129312, 0316729051538, 0316729049313, 0316729050531
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

N416729004853 followed by a unit qualifier and the quantity

Package 16729-0048-53. 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 May 23, 2025.

Indications (excerpt from the label)

Temozolomide is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma Temozolomide capsule is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma Temozolomide capsule is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocyt…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201528

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

FDA NDC Directory listings under ANDA 201528
Product	Strength	Form · route	Labeler	Product NDC
Temozolomide	Temozolomide 20 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-049
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-050
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-051
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-129
Temozolomide	Temozolomide 180 mg/1	CapsuleOral	Accord Healthcare Inc.	16729-130