Prescription drug · ANDA
Proparacaine Hydrochloride NDC 85766-039
Proparacaine hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-039-15 | 85766003915 | 1 BOTTLE in 1 CARTON (85766-039-15) / 15 mL in 1 BOTTLEMarketed from Aug 7, 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 LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215816
- Marketing start
- Listing expires
- Other FDA classes
- Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 85766-039_4a2b9e71-3e36-77a2-e063-6394a90a600eSPL ID 4a2b9e71-3e36-77a2-e063-6394a90a600eSPL set ID 4ae89863-233f-4015-92da-aad0f2a87677RxCUI 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
N485766003915followed by a unit qualifier and the quantityPackage 85766-0039-15. 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 topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.
Excerpt only. Read the full label for complete information.
About NDC 85766-039
- What is NDC 85766-039?
- 85766-039 is the product NDC for Proparacaine Hydrochloride, Proparacaine hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Sportpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Proparacaine Hydrochloride.
- What is the active ingredient?
- Proparacaine hydrochloride.
- Who is the labeler?
- Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Proparacaine Hydrochloride?
- 11 other product NDCs are listed under this name. See all Proparacaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Proparacaine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Proparacaine hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-497 | 42571-0497-57 |
| Proparacaine hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-193 | 70756-0193-35 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-601 | 70069-0601-01 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3408 | 70518-3408-00 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc. | 61314-016 | 61314-0016-01 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-056 | 85766-0056-15 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-730 | 24208-0730-06 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1923 | 50090-1923-00 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4368 | 68071-4368-05 |
| Proparacaine Hydrochloride | Proparacaine hydrochloride 5 mg/mL | Solution/ dropsOphthalmic | Sportpharm LLC | 85766-057 | 85766-0057-15 |
Other NDCs under ANDA 215816
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 | Somerset Therapeutics, LLC | 70069-601 |