Viewing data from:

ZAFIRLUKAST

ANDA

ZAFIRLUKAST | A090372 | DR REDDYS LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ACCOLATE(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.6762

per ea

Lowest NADAC/Unit

$0.5414

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68084005921ZAFIRLUKAST 20 MG TABLET	$0.6762	EA	Generic	—	2026-06-17
55111062660ZAFIRLUKAST 20 MG TABLET	$0.6762	EA	Generic	—	2026-06-17
55111062560ZAFIRLUKAST 10 MG TABLET	$0.5414	EA	Generic	—	2026-06-17

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

API Supply Chain4 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDZAFIRLUKAST (AMORPHOUS)

DMF 213132008

CHROMO LABORATORIES INDIA PRIVATE LTDZAFIRLUKAST PREMIX-50% W/W

DMF 263592012

CHROMO LABORATORIES INDIA PRIVATE LTDZAFIRLUKAST

DMF 318692017

HETERO DRUGS LTDZAFIRLUKAST (AMORPHOUS)

DMF 324152018

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 22, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 18, 2010

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 18, 2010