What is NDC 69097-516?

69097-516 is the product NDC for Cyclophosphamide, Cyclophosphamide 25 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-516 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0516Add 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
69097-516-07	6909705160769097051607	100 CAPSULE in 1 BOTTLE (69097-516-07)Marketed from Jan 18, 2019

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): Cyclophosphamide
Generic name (nonproprietary): cyclophosphamide
Active ingredients: Cyclophosphamide — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211608
Marketing start: Jan 18, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 69097-516_11c7b59d-18e5-4efb-bc77-5877d9b89bb1SPL ID 11c7b59d-18e5-4efb-bc77-5877d9b89bb1SPL set ID 0e1cb955-99c8-4fe5-89d1-399c8e52174eRxCUI 1437968, 1437969UNII 8N3DW7272PUPC 0369097517076

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

N469097051607 followed by a unit qualifier and the quantity

Package 69097-0516-07. 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 10, 2025.

Indications (excerpt from the label)

Cyclophosphamide capsules, USP 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-516

What is NDC 69097-516?: 69097-516 is the product NDC for Cyclophosphamide, Cyclophosphamide 25 mg/1 capsule, listed with the FDA by Cipla USA 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?: Cipla USA Inc., NDC labeler code 69097. 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 50 mg/1	CapsuleOral	OPKO Pharmaceuticals, LLC	70301-2015	70301-2015-01
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

All 84 Cyclophosphamide NDCs

Other NDCs under ANDA 211608

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

FDA NDC Directory listings under ANDA 211608
Product	Strength	Form · route	Labeler	Product NDC
Cyclophosphamide	Cyclophosphamide 50 mg/1	CapsuleOral	Cipla USA Inc.	69097-517