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DANTROLENE SODIUM

ANDA

DANTROLENE SODIUM | A076686 | ELITE LABORATORIES INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DANTRIUM(TE code: AB)

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$0.8473

per ea

Lowest NADAC/Unit

$0.4539

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64850084201DANTROLENE SODIUM 100 MG CAP	$0.8473	EA	Generic	—	2026-06-17
64850084101DANTROLENE SODIUM 50 MG CAP	$0.5995	EA	Generic	—	2026-06-17
64850084001DANTROLENE SODIUM 25 MG CAP	$0.4539	EA	Generic	—	2026-06-17

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

API Supply Chain6 active DMFs1 inactive

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

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTDDANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 151672000

SCINOPHARM TAIWAN LTDDANTROLENE SODIUM USP

DMF 161182002

HAS HEALTHCARE ADVANCED SYNTHESIS SADANTROLENE SODIUM DRUG SUBSTANCE

DMF 194982006

VERANOVA LPDANTROLENE SODIUM (DTE)

DMF 207792007

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDANTROLENE SODIUM

DMF 338452019

GLAND PHARMA LTDDANTROLENE SODIUM

DMF 393052024

FDC LTDInactiveDANTROLENE SODIUM

DMF 174462004

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

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 24, 2005

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 24, 2005

#003 — 100MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 24, 2005