Prescription drug · ANDA
Travoprost Ophthalmic Solution NDC 68083-601
Travoprost .04 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-601-01 | 68083060101 | 1 BOTTLE in 1 CARTON (68083-601-01) / 2.5 mL in 1 BOTTLEMarketed from Jul 12, 2024 |
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)
- Travoprost Ophthalmic Solution
- Generic name (nonproprietary)
- travoprost ophthalmic solution
- Active ingredients
- Travoprost — .04 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218159
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 68083-601_7c35e414-614e-4d70-96ff-3adae7238166SPL ID 7c35e414-614e-4d70-96ff-3adae7238166SPL set ID 71c9ea95-f577-411a-8e22-819e44d9680eRxCUI 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
N468083060101followed by a unit qualifier and the quantityPackage 68083-0601-01. 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 68083-601
- What is NDC 68083-601?
- 68083-601 is the product NDC for Travoprost Ophthalmic Solution, Travoprost .04 mg/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Travoprost Ophthalmic Solution.
- What is the active ingredient?
- Travoprost.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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?
- 4 other product NDCs are listed under this name. See all Travoprost Ophthalmic Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Travoprost Ophthalmic Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Travoprost ophthalmic solutiontravoprost ophthalmic | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-625 | 62332-0625-0262332-0625-05 |
| Travoprost ophthalmic solutiontravoprost ophthalmic | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-625 | 46708-0625-0246708-0625-05 |
| Travoprost Ophthalmic Solution | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | GLENMARK PHARMACEUTICALS INC | 68462-943 | 68462-0943-0368462-0943-05 |
| Travoprost Ophthalmic Solution | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-602 | 68083-0602-01 |
Other NDCs under ANDA 218159
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Travoprost Ophthalmic Solutontravoprost | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | Sagent Pharmaceuticals | 25021-002 |
| Travoprost Ophthalmic Solution | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | GLENMARK PHARMACEUTICALS INC | 68462-943 |
| Travoprost Ophthalmic Solution | Travoprost .04 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-602 |