What is NDC 70301-2015?

70301-2015 is the product NDC for Cyclophosphamide, Cyclophosphamide 50 mg/1 capsule, listed with the FDA by OPKO Pharmaceuticals, LLC. It has 1 package NDC, 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 Cyclophosphamide?

83 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclophosphamide NDC 70301-2015 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70301-2015Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70301-2015Add 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
70301-2015-1	70301201501	100 CAPSULE in 1 BOTTLE (70301-2015-1)Marketed from Apr 20, 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): Cyclophosphamide
Generic name (nonproprietary): cyclophosphamide
Active ingredients: Cyclophosphamide — 50 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 218282
Marketing start: Apr 20, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 70301-2015_4ffc80f0-4804-ada3-e063-6294a90acf7bSPL ID 4ffc80f0-4804-ada3-e063-6294a90acf7bSPL set ID 7d6447e3-22c9-48d9-87c0-d0b576d7ea9eRxCUI 1437969UNII 8N3DW7272PUPC 0370301201513

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

N470301201501 followed by a unit qualifier and the quantity

Package 70301-2015-01. 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

Current FDA label (SPL), effective Apr 21, 2026.

Indications (excerpt from the label)

Cyclophosphamide is an alkylating drug indicated for treatment of: Malignant Diseases : malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma (1.1) Minimal Change Nephrotic Syndrome in Pediatric Patients : biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy (1.2) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70301-2015

What is NDC 70301-2015?: 70301-2015 is the product NDC for Cyclophosphamide, Cyclophosphamide 50 mg/1 capsule, listed with the FDA by OPKO Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cyclophosphamide.
What is the active ingredient?: Cyclophosphamide.
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 Cyclophosphamide?: 83 other product NDCs are listed under this name. See all Cyclophosphamide 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 Cyclophosphamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclophosphamide	Cyclophosphamide 25 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2013	70301-2013-01
Cyclophosphamide	Cyclophosphamide 200 mg/mL	InjectionIntravenous	Nexus Pharmaceuticals, LLC	14789-125	14789-0125-05
Cyclophosphamide	Cyclophosphamide 200 mg/mL	InjectionIntravenous	Nexus Pharmaceuticals, LLC	14789-126	14789-0126-05
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-694	68001-0694-27
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-695	68001-0695-32
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	BluePoint Laboratories	68001-696	68001-0696-32
Cyclophosphamide	Cyclophosphamide 500 mg/25mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-205	83634-0205-50
Cyclophosphamide	Cyclophosphamide 1 g/50mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-206	83634-0206-51
Cyclophosphamide	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous, Oral	Avenacy, LLC	83634-207	83634-0207-51
Cyclophosphamidecyclophosphamide for injection	Cyclophosphamide 2 g/100mL	Injection, Powder, For solutionIntravenous	Slate Run Pharmaceuticals, LLC	70436-107	70436-0107-80

All 84 Cyclophosphamide NDCs

Other NDCs under ANDA 218282

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

FDA NDC Directory listings under ANDA 218282
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamide	Cyclophosphamide 25 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2013