Prescription drug · NDA
Xelpros (Latanoprost) NDC 47335-317
Latanoprost .05 mg/mL · Solution/ drops · Ophthalmic, Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-317-90 | 4733503179047335031790 | 1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Sep 12, 2018 | |
| 47335-317-92 | 4733503179247335031792 | 3 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Sep 12, 2018 | |
| 47335-317-94 | 4733503179447335031794 | 3 BOTTLE, DROPPER in 1 BOX (47335-317-94) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Sep 12, 2018 · Sample package | |
| 47335-317-98 | 4733503179847335031798 | 1 BOTTLE, DROPPER in 1 BOX (47335-317-98) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Sep 12, 2018 · Sample package |
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)
- Xelpros
- Generic name (nonproprietary)
- latanoprost
- Active ingredients
- Latanoprost — .05 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic, Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206185
- Marketing start
- Listing expires
- Identifiers
- Product ID 47335-317_44b8ddc0-81dc-4613-bbe8-0da960cc179cSPL ID 44b8ddc0-81dc-4613-bbe8-0da960cc179cSPL set ID 34ad5cf6-4df0-4104-bddd-4c7631133dedRxCUI 2056743, 2056748UNII 6Z5B6HVF6O
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, Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N447335031790followed by a unit qualifier and the quantityPackage 47335-0317-90. 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)
XELPROS (latanoprost ophthalmic emulsion) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. XELPROS is a prostaglandin F 2α analog indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 47335-317
- What is NDC 47335-317?
- 47335-317 is the product NDC for Xelpros (latanoprost), Latanoprost .05 mg/mL solution/ drops, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xelpros (Latanoprost).
- What is the active ingredient?
- Latanoprost.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xelpros?
- 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.