NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3255Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3255Add 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
0781-3255-9400781325594007813255941 VIAL, SINGLE-DOSE in 1 CARTON (0781-3255-94) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 31, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Cyclophosphamide
Generic name (nonproprietary)
cyclophosphamide
Active ingredients
Cyclophosphamide — 2 g/100mL
Dosage form
Injection, Powder, For solution
Route
Intravenous, Oral
Labeler
Sandoz Inc.NDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204555
Marketing start
Listing expires
Identifiers
Product ID 0781-3255_2f9d08d0-1f6c-0bf3-e063-6394a90a2b6fSPL ID 2f9d08d0-1f6c-0bf3-e063-6394a90a2b6fSPL set ID 0e9e22fa-178a-42fc-9f82-c303db3b245aRxCUI 1734917, 1734919, 1734921UNII 8N3DW7272PUPC 0307813233947, 0307813244943, 0307813255949

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400781325594 followed by a unit qualifier and the quantity

Package 00781-3255-94. 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 .

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 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 been establ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3255

What is NDC 0781-3255?
0781-3255 is the product NDC for Cyclophosphamide, Cyclophosphamide 2 g/100mL injection, powder, for solution, listed with the FDA by Sandoz Inc.. 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?
Sandoz Inc., NDC labeler code 0781. 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 25 mg/1CapsuleOralOPKO Pharmaceuticals, LLC70301-201370301-2013-01
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

All 84 Cyclophosphamide NDCs

Other NDCs under ANDA 204555

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

FDA NDC Directory listings under ANDA 204555
ProductStrengthForm · routeLabelerProduct NDC
CyclophosphamideCyclophosphamide 500 mg/25mLInjection, Powder, For solutionIntravenous, OralSandoz Inc.0781-3233
CyclophosphamideCyclophosphamide 1 g/50mLInjection, Powder, For solutionIntravenous, OralSandoz Inc.0781-3244
CyclophosphamideCyclophosphamide 1 g/50mLInjection, Powder, For solutionIntravenous, OralNorthStar Rx LLC16714-857
CyclophosphamideCyclophosphamide 2 g/100mLInjection, Powder, For solutionIntravenous, OralNorthStar Rx LLC16714-858
CyclophosphamideCyclophosphamide 500 mg/25mLInjection, Powder, For solutionIntravenous, OralNorthStar Rx LLC16714-859
CyclophosphamideCyclophosphamide 1 g/50mLInjection, Powder, For solutionIntravenous, OralFresenius Kabi USA, LLC65219-131
CyclophosphamideCyclophosphamide 2 g/100mLInjection, Powder, For solutionIntravenous, OralFresenius Kabi USA, LLC65219-133
CyclophosphamideCyclophosphamide 500 mg/25mLInjection, Powder, For solutionIntravenous, OralFresenius Kabi USA, LLC65219-135

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