What is NDC 70301-2009?

70301-2009 is the product NDC for Temozolomide, Temozolomide 180 mg/1 capsule, listed with the FDA by OPKO Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

OPKO Pharmaceuticals, LLC, NDC labeler code 70301. 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 70301-2009 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70301-2009Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70301-2009Add 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
70301-2009-1	7030120090170301200901	5 PACKET in 1 CARTON (70301-2009-1) / 1 CAPSULE in 1 PACKETMarketed from Sep 16, 2026
70301-2009-2	7030120090270301200902	14 PACKET in 1 CARTON (70301-2009-2) / 1 CAPSULE in 1 PACKETMarketed from Sep 16, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: OPKO Pharmaceuticals, LLCNDC labeler code 70301
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203898
Marketing start: Sep 16, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 70301-2009_5ca61c92-6979-0a76-e063-6294a90a7d25SPL ID 5ca61c92-6979-0a76-e063-6294a90a7d25
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

N470301200901 followed by a unit qualifier and the quantity

Package 70301-2009-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70301-2009

What is NDC 70301-2009?: 70301-2009 is the product NDC for Temozolomide, Temozolomide 180 mg/1 capsule, listed with the FDA by OPKO Pharmaceuticals, 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?: OPKO Pharmaceuticals, LLC, NDC labeler code 70301. 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 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
Temozolomide	Temozolomide 5 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-411	31722-0411-1431722-0411-31

All 64 Temozolomide NDCs

Other NDCs under ANDA 203898

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

FDA NDC Directory listings under ANDA 203898
Product	Strength	Form · route	Labeler	Product NDC
Temozolomide	Temozolomide 100 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2005
Temozolomide	Temozolomide 140 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2007
Temozolomide	Temozolomide 250 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2011