Prescription drug · ANDA
Proparacaine Hydrochloride NDC 85766-057
Proparacaine hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-057-15 | 85766005715 | 1 BOTTLE, DROPPER in 1 CARTON (85766-057-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Aug 22, 2025 |
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)
- Proparacaine Hydrochloride
- Generic name (nonproprietary)
- proparacaine hydrochloride
- Active ingredients
- Proparacaine hydrochloride — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040074
- Marketing start
- Listing expires
- Other FDA classes
- Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 85766-057_502f0591-7636-2e7b-e063-6294a90a6e98SPL ID 502f0591-7636-2e7b-e063-6294a90a6e98SPL set ID 509fed7b-637b-418c-93cd-19f49ba8740cRxCUI 1191013UNII U96OL57GOY
- Pharmacologic class
- Local Anesthetic
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
N485766005715followed by a unit qualifier and the quantityPackage 85766-0057-15. 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)
INDICATIONS AND USAGE Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated; corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies and for short corneal and conjunctival procedures.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040074
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 |
|---|---|---|---|---|
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4368 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1923 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-730 |