NDC codes

FDA NDC Directory
Product NDC (as listed)0378-9651Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00378-9651Add 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
0378-9651-32003789651321 BOTTLE in 1 CARTON (0378-9651-32) / 2.5 mL in 1 BOTTLEMarketed from Dec 18, 2019
0378-9651-50003789651501 BOTTLE in 1 CARTON (0378-9651-50) / 5 mL in 1 BOTTLEMarketed from Dec 18, 2019

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

Generic name (nonproprietary)
travoprost ophthalmic solution, 0.004%
Active ingredients
Travoprost — .04 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205050
Marketing start
Listing expires
Other FDA classes
Prostaglandins (Chemical structure)
Identifiers
Product ID 0378-9651_d78c5705-68ac-4363-b9ae-5facc60e2b79SPL ID d78c5705-68ac-4363-b9ae-5facc60e2b79SPL set ID 00dc284f-fd96-423b-bb8f-b90ee13439bfRxCUI 284008UNII WJ68R08KX9
Pharmacologic class
Prostaglandin Analog

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

N400378965132 followed by a unit qualifier and the quantity

Package 00378-9651-32. 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)

Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Travoprost ophthalmic solution (ionic buffered solution) is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-9651

What is NDC 0378-9651?
0378-9651 is the product NDC for Travoprost Ophthalmic Solution, 0.004%, Travoprost .04 mg/mL solution/ drops, 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?
Travoprost Ophthalmic Solution, 0.004%.
What is the active ingredient?
Travoprost.
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 Travoprost Ophthalmic Solution, 0.004%?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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