Viewing data from:

DICLOFENAC SODIUM

ANDA

DICLOFENAC SODIUM | A213040 | AUROLIFE PHARMA LLC

1 strength0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$0.3625

per gm

Lowest NADAC/Unit

$0.3625

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72603020701DICLOFENAC 2% SOLUTION PUMP	$0.3625	GM	Generic	—	2026-06-17
13107026947DICLOFENAC 2% SOLUTION PUMP	$0.3625	GM	Generic	—	2026-06-17

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

API Supply Chain12 active DMFs12 inactive

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

DIPHARMA FRANCIS SRLDICLOFENAC SODIUM EP/USP

DMF 66891986

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC SODIUM

DMF 69811987

CHENG FONG CHEMICAL CO LTDDICLOFENAC SODIUM

DMF 81921989

OLON SPADICLOFENAC SODIUM

DMF 89241991

SYN-TECH CHEM AND PHARM CO LTDDICLOFENAC SODIUM USP

DMF 98991992

UNIQUE CHEMICALSDICLOFENAC SODIUM USP

DMF 124691997

NINGBO SMART PHARMACEUTICAL CO LTDDICLOFENAC SODIUM

DMF 188772005

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DICLOFENAC SODIUM USP

DMF 208492007

HENAN DONGTAI PHARM CO LTDDICLOFENAC SODIUM

DMF 245802011

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC SODIUM (PROCESS II)

DMF 353632020

MACLEODS PHARMACEUTICALS LTDDICLOFENAC SODIUM USP

DMF 381552023

KREATIVE ORGANICS PRIVATE LTDDICLOFENAC SODIUM USP

DMF 424612025

HEUMANN PCS GMBHInactiveDICLOFENAC SODIUM

DMF 81211989

PROSINTEX SPAInactiveDICLOFENAC SODIUM

DMF 85831990

YONEZAWA HAMARI CHEMICALS LTDInactiveDICLOFENAC SODIUM

DMF 86881990

MEDICHEM SAInactiveDICLOFENAC SODIUM

DMF 89161991

ESTEVE QUIMICA SAInactiveDICLOFENAC SODIUM

DMF 91151991

IROTEC LABORATORIESInactiveDICLOFENAC SODIUM

DMF 103601993

ASSIA CHEMICAL INDUSTRIES LTDInactiveDICLOFENAC SODIUM

DMF 114991995

AMOLI ORGANICS LTDInactiveDICLOFENAC SODIUM

DMF 116761995

FARCHEMIA SRLInactiveDICLOFENAC SODIUM

DMF 117001995

EXCELLA GMBHInactiveDICLOFENAC SODIUM

DMF 151812000

ESTEVE QUIMICA SAInactiveDICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE

DMF 232002009

HAINAN POLY PHARMACEUTICAL CO LTDInactiveDICLOFENAC SODIUM EXTENDED RELEASE CAPSULES

DMF 232432009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Feb 3, 2023

No patent or exclusivity listings for this strength.