Prescription drug · ANDA
Travoprost Ophthalmic Solution, 0.004% NDC 0378-9651
Travoprost .04 mg/mL · Solution/ drops · Ophthalmic · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-9651-32 | 00378965132 | 1 BOTTLE in 1 CARTON (0378-9651-32) / 2.5 mL in 1 BOTTLEMarketed from Dec 18, 2019 | |
| 0378-9651-50 | 00378965150 | 1 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
- Brand name (proprietary)
- Travoprost Ophthalmic Solution, 0.004%
- 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
N400378965132followed by a unit qualifier and the quantityPackage 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.
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.