What is NDC 0378-8760?

0378-8760 is the product NDC for Cyclosporine, Cyclosporine .5 mg/mL emulsion, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclosporine NDC 0378-8760 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8760Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8760Add 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
0378-8760-58	0037887605800378876058	6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Feb 3, 2022
0378-8760-91	0037887609100378876091	12 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USEMarketed from Feb 3, 2022

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): Cyclosporine
Generic name (nonproprietary): cyclosporine
Active ingredients: Cyclosporine — .5 mg/mL
Dosage form: Emulsion
Route: Ophthalmic
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205894
Marketing start: Feb 3, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13SPL ID da3fa070-b512-4568-871a-dc8d5a949d13SPL set ID da3fa070-b512-4568-871a-dc8d5a949d13RxCUI 2572292UNII 83HN0GTJ6DUPC 0303788760587, 0303788760914
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378876058 followed by a unit qualifier and the quantity

Package 00378-8760-58. 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 20, 2022.

Indications (excerpt from the label)

Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-8760

What is NDC 0378-8760?: 0378-8760 is the product NDC for Cyclosporine, Cyclosporine .5 mg/mL emulsion, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Cipla USA Inc.	69097-292	69097-0292-0369097-0292-97
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-927	59651-0927-03
Cyclosporine	Cyclosporine 50 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-928	59651-0928-65
Cyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Aurobindo Pharma Limited	59651-929	59651-0929-65
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Upsher-Smith Laboratories, LLC	24979-126	24979-0126-1824979-0126-19
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Saptalis Pharmaceuticals, LLC	71656-012	71656-0012-3071656-0012-60
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Teva Pharmaceuticals, Inc.	0480-4076	00480-4076-3000480-4076-60
Cyclosporine	Cyclosporine .5 mg/mL	EmulsionOphthalmic	Devatis Inc.	73043-005	73043-0005-0173043-0005-02
Cyclosporine	Cyclosporine 25 mg/1	Capsule, Liquid filledOral	Dr. Reddy's Laboratories Inc	75907-047	75907-0047-30
Cyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Dr. Reddy's Laboratories Inc	75907-048	75907-0048-30

All 25 Cyclosporine NDCs