Alcaine (proparacaine hydrochloride) NDC 0998-0016

NDC codes

FDA NDC Directory

Product NDC (as listed)0998-0016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00998-0016Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0998-0016-15	00998001615	1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLEMarketed from Oct 19, 1973

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Alcaine
Generic name (nonproprietary): proparacaine hydrochloride
Active ingredients: Proparacaine hydrochloride — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alcon Laboratories, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080027
Marketing start: Oct 19, 1973
Listing expires: Dec 31, 2027
Other FDA classes: Local Anesthesia (Physiologic effect)
Identifiers: Product ID 0998-0016_2060dc26-3548-4b86-900c-ef53b5f453a2SPL ID 2060dc26-3548-4b86-900c-ef53b5f453a2SPL set ID 0c0fa0bf-977d-4539-b8dc-54c187c5b094RxCUI 1191013, 1191026UNII 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

N400998001615 followed by a unit qualifier and the quantity

Package 00998-0016-15. 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 Jun 10, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE: ALCAINE™ 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 080027

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 080027
Product	Strength	Form · route	Labeler	Product NDC
proparacaine hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals,Inc.	68071-5139
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-056
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	REMEDYREPACK INC.	70518-3408
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc.	61314-016