Prescription drug · ANDA
Proparacaine hydrochloride NDC 42571-497
Proparacaine hydrochloride 5 mg/mL · Solution/ drops · Ophthalmic · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-497-57 | 42571049757 | 1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLEMarketed from Feb 1, 2026 |
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
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219294
- Marketing start
- Listing expires
- Other FDA classes
- Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124SPL ID 41be90a9-dfee-6fcc-e063-6394a90a4124SPL set ID df1af0e8-7d9d-4511-9d86-f0c31a5da2c2RxCUI 1191013UNII U96OL57GOYUPC 0342571497576
- 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
N442571049757followed by a unit qualifier and the quantityPackage 42571-0497-57. 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.