NDC codes

FDA NDC Directory
Product NDC (as listed)23155-838Labeler and product segments. Claims need a package NDC.
Product NDC at billing width23155-0838Add 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
23155-838-3023155083830231550838306 BLISTER PACK in 1 CARTON (23155-838-30) / 5 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-838-11)Marketed from Nov 30, 2022

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)
Cyclosporine
Generic name (nonproprietary)
cyclosporine
Active ingredients
Cyclosporine — 50 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216046
Marketing start
Listing expires
Other FDA classes
Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 23155-838_15185077-eec3-40ca-a492-f500a05a045bSPL ID 15185077-eec3-40ca-a492-f500a05a045bSPL set ID 1952d4c7-a40e-4924-b669-c41400774cb9RxCUI 241834, 835894, 835925UNII 83HN0GTJ6DUPC 0323155839302
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

N423155083830 followed by a unit qualifier and the quantity

Package 23155-0838-30. 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 Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclosporine capsules (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 23155-838

What is NDC 23155-838?
23155-838 is the product NDC for Cyclosporine, Cyclosporine 50 mg/1 capsule, liquid filled, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. 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?
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. 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 216046

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

FDA NDC Directory listings under ANDA 216046
ProductStrengthForm · routeLabelerProduct NDC
CyclosporineCyclosporine 25 mg/1Capsule, Liquid filledOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-837
CyclosporineCyclosporine 100 mg/1Capsule, Liquid filledOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-839
CyclosporineCyclosporine 25 mg/1Capsule, Liquid filledOralStrides Pharma Science Limited64380-127
CyclosporineCyclosporine 50 mg/1Capsule, Liquid filledOralStrides Pharma Science Limited64380-128
CyclosporineCyclosporine 100 mg/1Capsule, Liquid filledOralStrides Pharma Science Limited64380-129

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