NDC codes

FDA NDC Directory
Product NDC (as listed)60505-0134Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-0134Add 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
60505-0134-0605050134006050501340030 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0)Marketed from May 29, 2002

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)
Cyclosporine
Generic name (nonproprietary)
cyclosporine
Active ingredients
Cyclosporine — 100 mg/1
Dosage form
Capsule, Gelatin coated
Route
Oral
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065040
Marketing start
Listing expires
Other FDA classes
Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 60505-0134_561ed7a8-f342-f4fe-ce36-998d87c33e7fSPL ID 561ed7a8-f342-f4fe-ce36-998d87c33e7fSPL set ID bfca7088-fe93-abb9-3ec3-e6f5710a69c6RxCUI 197553, 328160UNII 83HN0GTJ6D
Pharmacologic class
Calcineurin Inhibitor Immunosuppressant

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

N460505013400 followed by a unit qualifier and the quantity

Package 60505-0134-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cyclosporine capsules, (NON-MODIFIED), in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-0134

What is NDC 60505-0134?
60505-0134 is the product NDC for Cyclosporine, Cyclosporine 100 mg/1 capsule, gelatin coated, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cyclosporine.
What is the active ingredient?
Cyclosporine.
Who is the labeler?
Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cyclosporine?
24 other product NDCs are listed under this name. See all Cyclosporine 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 Cyclosporine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CyclosporineCyclosporine .5 mg/mLEmulsionOphthalmicCipla USA Inc.69097-29269097-0292-0369097-0292-97
CyclosporineCyclosporine 25 mg/1Capsule, Liquid filledOralAurobindo Pharma Limited59651-92759651-0927-03
CyclosporineCyclosporine 50 mg/1Capsule, Liquid filledOralAurobindo Pharma Limited59651-92859651-0928-65
CyclosporineCyclosporine 100 mg/1Capsule, Liquid filledOralAurobindo Pharma Limited59651-92959651-0929-65
CyclosporineCyclosporine .5 mg/mLEmulsionOphthalmicUpsher-Smith Laboratories, LLC24979-12624979-0126-1824979-0126-19
CyclosporineCyclosporine .5 mg/mLEmulsionOphthalmicSaptalis Pharmaceuticals, LLC71656-01271656-0012-3071656-0012-60
CyclosporineCyclosporine .5 mg/mLEmulsionOphthalmicTeva Pharmaceuticals, Inc.0480-407600480-4076-3000480-4076-60
CyclosporineCyclosporine .5 mg/mLEmulsionOphthalmicDevatis Inc.73043-00573043-0005-0173043-0005-02
CyclosporineCyclosporine 25 mg/1Capsule, Liquid filledOralDr. Reddy's Laboratories Inc75907-04775907-0047-30
CyclosporineCyclosporine 100 mg/1Capsule, Liquid filledOralDr. Reddy's Laboratories Inc75907-04875907-0048-30

All 25 Cyclosporine NDCs

Other NDCs under ANDA 065040

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

FDA NDC Directory listings under ANDA 065040
ProductStrengthForm · routeLabelerProduct NDC
CyclosporineCyclosporine 25 mg/1Capsule, Gelatin coatedOralApotex Corp.60505-0133
CyclosporineCyclosporine 25 mg/1Capsule, Gelatin coatedOralAmerican Health Packaging68084-879
CyclosporineCyclosporine 100 mg/1Capsule, Gelatin coatedOralAmerican Health Packaging68084-921

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