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GUAIFENESIN

ANDA

GUAIFENESIN | A207342 | AMNEAL PHARMACEUTICALS OF NEW YORK LLC

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.4491

per ea

Lowest NADAC/Unit

$0.2912

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70677105101FT MUCUS RELIEF ER 1,200 MG TB	$0.4491	EA	Generic	—	2026-06-17
00904671839MUCUS RELIEF ER 600 MG TABLET	$0.2912	EA	Generic	—	2026-06-17
00536116361GUAIFENESIN ER 600 MG TABLET	$0.2912	EA	Generic	—	2026-06-17
70677105201FT MUCUS RELIEF ER 600 MG TAB	$0.2912	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$31.14

Highest Price

$54.92

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00904-6718-39GUAIFENESIN 600MG TAB,SA UD	$54.92	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030
00536-1163-61GUAIFENESIN 600MG TAB,SA	$31.14	FSS	The Harvard Drug Group L.L.C. dba Major Pharmaceuticals and Rugby Labs	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs13 inactive

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

DELTA SYNTHETIC CO LTDGUAIFENESIN

DMF 58091985

SYNTHOKEM LABS PRIVATE LTDGUAIFENESIN USP

DMF 104131993

GRANULES INDIA LTDGUAIFENESIN USP

DMF 143721999

SEVEN STAR PHARMACEUTICAL CO LTDGUAIFENESIN USP

DMF 161222002

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDGUAIFENESIN

DMF 291792015

GANES CHEMICALS INC PENNSVILLE DIVInactiveGUAIFENESIN GLYCERYLGUAIACOLATE

DMF 25021975

PEBOC LTDInactiveGUAIFENESIN USP

DMF 48661983

RHODIA OPERATIONSInactiveGUAIFENESIN (GLYCEROL GUAIACOLATE)

DMF 49891983

CHINA NATIONAL CHEMICAL IMPORT AND EXPORT CORPInactiveGUAIFENESIN USP

DMF 54231984

BOEHRINGER INGELHEIM CHEMICALS INCInactiveGUAIFENESIN

DMF 59721985

CHEMSPEC CHEMICALS PVT LTDInactiveGUAIFENESIN

DMF 92621991

SIANG TA PHARMACEUTICAL CO LTDInactiveGUAIFENESIN

DMF 109881994

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveGUAIFENESIN USP

DMF 142341999

BOEHRINGER INGELHEIM CHEMICALS INCInactiveGUAIFENESIN USP

DMF 155072001

NINGBO SMART PHARMACEUTICAL CO LTDInactiveGUAIFENESIN USP

DMF 180292005

ZHEJIANG JIANFENG HAIZHOU PHARMACEUTICAL CO LTDInactiveGUAIFENESIN

DMF 228402009

PAN DRUGS LTDInactiveGUAIFENESIN USP

DMF 257522012

PAN DRUGS LTDInactiveGUAIFENESIN USP (NEW ROUTE)

DMF 263242012

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

Products (2)

Sort:

#001 — 600MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 11, 2018

No patent or exclusivity listings for this strength.

#002 — 1.2GM

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 11, 2018