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HALCINONIDE

ANDA

HALCINONIDE | A217671 | ENCUBE ETHICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: HALOG(TE code: AT)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$6.08

per ml

Lowest NADAC/Unit

$6.08

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
74157001212HALCINONIDE 0.1% SOLUTION	$6.08	ML	Generic	—	2026-03-18

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

API Supply Chain1 active DMF3 inactive

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

FARMABIOS SPAHALCINONIDE

DMF 183522005

BRISTOL MYERS SQUIBB COInactiveHALCINONIDE BULK

DMF 22031973

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveHALCINONIDE

DMF 74481988

FARMABOISInactiveHALCINONIDE

DMF 83351989

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 20, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: May 29, 2024

No patent or exclusivity listings for this strength.