NDC codes

FDA NDC Directory
Product NDC (as listed)70301-2013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70301-2013Add 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 NDC11-digit (billing)PackageCopy
70301-2013-170301201301100 CAPSULE in 1 BOTTLE (70301-2013-1)Marketed 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)
Cyclophosphamide
Generic name (nonproprietary)
cyclophosphamide
Active ingredients
Cyclophosphamide — 25 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
Listing expires
Identifiers
Product ID 70301-2013_5c922933-a668-9f4b-e063-6294a90ae37fSPL ID 5c922933-a668-9f4b-e063-6294a90ae37f

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

N470301201301 followed by a unit qualifier and the quantity

Package 70301-2013-01. 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 70301-2013

What is NDC 70301-2013?
70301-2013 is the product NDC for Cyclophosphamide, Cyclophosphamide 25 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CyclophosphamideCyclophosphamide 50 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-201570301-2015-01
CyclophosphamideCyclophosphamide 200 mg/mLInjectionIntravenousNexus Pharmaceuticals, LLC14789-12514789-0125-05
CyclophosphamideCyclophosphamide 200 mg/mLInjectionIntravenousNexus Pharmaceuticals, LLC14789-12614789-0126-05
CyclophosphamideCyclophosphamide 500 mg/25mLInjection, Powder, For solutionIntravenous, OralBluePoint Laboratories68001-69468001-0694-27
CyclophosphamideCyclophosphamide 1 g/50mLInjection, Powder, For solutionIntravenous, OralBluePoint Laboratories68001-69568001-0695-32
CyclophosphamideCyclophosphamide 2 g/100mLInjection, Powder, For solutionIntravenous, OralBluePoint Laboratories68001-69668001-0696-32
CyclophosphamideCyclophosphamide 500 mg/25mLInjection, Powder, For solutionIntravenous, OralAvenacy, LLC83634-20583634-0205-50
CyclophosphamideCyclophosphamide 1 g/50mLInjection, Powder, For solutionIntravenous, OralAvenacy, LLC83634-20683634-0206-51
CyclophosphamideCyclophosphamide 2 g/100mLInjection, Powder, For solutionIntravenous, OralAvenacy, LLC83634-20783634-0207-51
Cyclophosphamidecyclophosphamide for injectionCyclophosphamide 500 mg/25mLInjection, Powder, For solutionIntravenousSlate Run Pharmaceuticals, LLC70436-10570436-0105-80

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
ProductStrengthForm · routeLabelerProduct NDC
CyclophosphamideCyclophosphamide 50 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-2015

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