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ALCAINE

ANDA

PROPARACAINE HYDROCHLORIDE | A080027 | ALCON LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner LLP FDA-2020-P-1260 · 7 docket documents Foley & Lardner LLP submitted this citizen petition under Section 505(j)(2)(C) of the FDC Act requesting that the FDA designate ALCAINE (Proparacaine Hydrochloride) Ophthalmic Solution 0.5%, ANDA A080027 held by Alcon Laboratories Inc., as an additional reference standard to enable development of a	Other	2020-04-07	Withdrawn	Foley & Lardner LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$1.60

per ml

Lowest NADAC/Unit

$1.60

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61314001601PROPARACAINE 0.5% EYE DROPS	$1.60	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SIEGFRIED LTDPROPARACAINE HYDROCHLORIDE

DMF 26981976

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.