What is NDC 67877-541?

67877-541 is the product NDC for Temozolomide, Temozolomide 180 mg/1 capsule, listed with the FDA by Ascend Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Temozolomide?

63 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Temozolomide NDC 67877-541 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67877-541Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67877-0541Add 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
67877-541-07	6787705410767877054107	5 CAPSULE in 1 BOTTLE (67877-541-07)Marketed from Apr 28, 2017
67877-541-14	6787705411467877054114	14 CAPSULE in 1 BOTTLE (67877-541-14)Marketed from Apr 28, 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 — 180 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Ascend Laboratories, LLCNDC labeler code 67877
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207658
Marketing start: Apr 28, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 67877-541_f519f4f0-bb62-43cb-bfc2-15f00ac1aad3SPL ID f519f4f0-bb62-43cb-bfc2-15f00ac1aad3SPL set ID 33d67bce-38ae-45fc-a858-d51167b0ecfdRxCUI 313209, 313210, 313211, 317160, 700883, 700885UNII YF1K15M17Y
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

N467877054107 followed by a unit qualifier and the quantity

Package 67877-0541-07. 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 Jan 9, 2025.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules, USP are 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 patient…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-541

What is NDC 67877-541?: 67877-541 is the product NDC for Temozolomide, Temozolomide 180 mg/1 capsule, listed with the FDA by Ascend Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Temozolomide.
What is the active ingredient?: Temozolomide.
Who is the labeler?: Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Temozolomide?: 63 other product NDCs are listed under this name. See all Temozolomide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Temozolomide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2005	70301-2005-0170301-2005-02
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2007	70301-2007-0170301-2007-02
Temozolomide	Temozolomide 180 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2009	70301-2009-0170301-2009-02
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2011	70301-2011-01
Temozolomide	Temozolomide 5 mg/1	CapsuleOral	CivicaScript LLC	82249-404	82249-0404-0582249-0404-14
Temozolomide	Temozolomide 20 mg/1	CapsuleOral	CivicaScript LLC	82249-406	82249-0406-0582249-0406-14
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	CivicaScript LLC	82249-408	82249-0408-0582249-0408-14
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	CivicaScript LLC	82249-410	82249-0410-0582249-0410-14
Temozolomide	Temozolomide 180 mg/1	CapsuleOral	CivicaScript LLC	82249-412	82249-0412-0582249-0412-14
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	CivicaScript LLC	82249-414	82249-0414-05

All 64 Temozolomide NDCs

Other NDCs under ANDA 207658

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

FDA NDC Directory listings under ANDA 207658
Product	Strength	Form · route	Labeler	Product NDC
Temozolomide	Temozolomide 5 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-537
Temozolomide	Temozolomide 20 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-538
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-539
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-540
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-542
Temozolomide	Temozolomide 5 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2659
Temozolomide	Temozolomide 20 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2660
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2661
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2662
Temozolomide	Temozolomide 180 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2663
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2664
Temozolomide	Temozolomide 5 mg/1	CapsuleOral	Devatis, Inc.	73043-011
Temozolomide	Temozolomide 20 mg/1	CapsuleOral	Devatis, Inc.	73043-012
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	Devatis, Inc.	73043-013
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	Devatis, Inc.	73043-014
Temozolomide	Temozolomide 180 mg/1	CapsuleOral	Devatis, Inc.	73043-015
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	Devatis, Inc.	73043-016
Temozolomide	Temozolomide 5 mg/1	CapsuleOral	CivicaScript LLC	82249-404
Temozolomide	Temozolomide 20 mg/1	CapsuleOral	CivicaScript LLC	82249-406
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	CivicaScript LLC	82249-408

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