Viewing data from:

SIMVASTATIN

ANDA

SIMVASTATIN | A078103 | LUPIN LTD

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ZOCOR(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 17 NDCs

Highest NADAC/Unit

$0.0996

per ea

Lowest NADAC/Unit

$0.0278

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68180046503SIMVASTATIN 80 MG TABLET	$0.0996	EA	Generic	—	2026-06-17
68180046506SIMVASTATIN 80 MG TABLET	$0.0996	EA	Generic	—	2026-06-17
68180046509SIMVASTATIN 80 MG TABLET	$0.0996	EA	Generic	—	2026-06-17
68180046403SIMVASTATIN 40 MG TABLET	$0.0534	EA	Generic	—	2026-06-17
68180046406SIMVASTATIN 40 MG TABLET	$0.0534	EA	Generic	—	2026-06-17
68180046409SIMVASTATIN 40 MG TABLET	$0.0534	EA	Generic	—	2026-06-17

Showing 6 of 17 NDCs.

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

API Supply Chain15 active DMFs28 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDSIMVASTATIN

DMF 145991999

LUPIN LTDSIMVASTATIN USP

DMF 179342004

BIOCON LTDSIMVASTATIN

DMF 184492005

JUBILANT BIOSYS LTDSIMVASTATIN USP

DMF 187552005

HENAN TOPFOND PHARMACEUTICAL CO LTDSIMVASTATIN, NON-STERILE BULK FORM

DMF 195452006

SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTDSIMVASTATIN USP

DMF 234252009

TEVA PHARMACEUTICAL INDUSTRIES LTDSIMVASTATIN (ETHANOL PROCESS)

DMF 250242011

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDSIMVASTATIN

DMF 269712013

HETERO LABS LTDSIMVASTATIN, USP (PROCESS II)

DMF 272312013

HENAN TOPFOND PHARMACEUTICAL CO LTDSIMVASTATIN AMMONIUM SALT(DRUG SUBSTANCE INTERMEDIATE)

DMF 278822014

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDSIMVASTATIN (WITH 0.01% BHA)

DMF 285832014

HENAN TOPFOND SCI-TECH CO LTDSIMVASTATIN AMMONIUM SALT (DRUG SUBSTANCE INTERMEDIATE)

DMF 327862018

HENAN TOPFOND SCI-TECH CO LTDSIMVASTATIN (DRUG SUBSTANCE)

DMF 340892019

THEMIS MEDICARE LTD DBA ARTEMIS BIOTECHSIMVASTATIN AMMONIUM SALT

DMF 398672024

ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO LTDSIMVASTATIN

DMF 403842024

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSIMVASTATIN USP

DMF 157222001

BIOCON LTDInactiveSIMVASTATIN USP

DMF 160942002

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveSIMVASTATIN USP

DMF 163052002

KREBS BIOCHEMICALS INDUSTRIES LTDInactiveSIMVASTATIN USP

DMF 171512004

LEK PHARMACEUTICALS DDInactiveSIMVASTATIN

DMF 175682004

APITORIA PHARMA PRIVATE LTDInactiveSIMVASTATIN USP

DMF 178292004

GLENMARK PHARMACEUTICALS LTDInactiveSIMVASTATIN

DMF 179592004

ZHEJIANG RUIBANG LABORATORIES INCInactiveSIMVASTATIN USP

DMF 181012005

CADILA HEALTHCARE LTDInactiveSIMVASTATIN

DMF 182232005

ZHEJIANG APELOA PHARMACEUTICAL CO LTDInactiveSIMVASTATIN USP BULK

DMF 183092005

SYNTHON BVInactiveSIMVASTATIN

DMF 183842005

ARTEMIS BIOTECHInactiveSIMVASTATIN USP

DMF 185222005

CONCORD BIOTECH LTDInactiveSIMVASTATIN USP

DMF 190442005

KREBS BIOCHEMICALS INDUSTRIES LTDInactiveSIMVASTATIN AMMONIUM SALT (INTERMEDIATE)

DMF 195362006

CADILA HEALTHCARE LTDInactiveSIMVASTATIN ( LOVASTATIN ROUTE)

DMF 201252007

CADILA HEALTHCARE LTDInactiveSIMVASTATIN (AMMONIUM SALT ROUTE)

DMF 203732007

MYLAN LABORATORIES LTDInactiveSIMVASTATIN USP

DMF 209032007

DR REDDYS LABORATORIES LTDInactiveSIMVASTATIN USP

DMF 212652008

SANDOZ INDUSTRIAL PRODUCTS SPAInactiveSIMVASTATIN

DMF 222832008

HETERO LABS LTDInactiveSIMVASTATIN

DMF 230122009

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveSIMVASTATIN AMMONIUM SALT

DMF 249352011

SOUTHWEST SYNTHETIC PHARMACEUTICAL CO LTDInactiveSIMVASTATIN AMMONIUM SALT

DMF 249672011

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveSIMVASTATIN (BHA ADDED) USP

DMF 260482012

ZHEJIANG JIANGBEI PHARMACEUTICAL CO LTDInactiveSIMVASTATIN AMMONIUM SALT (ALTERNATIVE PROCESS)

DMF 260882012

HEC PHARM USA INCInactiveSIMVASTATIN NON-STERILE DRUG SUBSTANCE, BULK FORM

DMF 268432013

HEC PHARM CO LTDInactiveSIMVASTATIN NON-STERILE BULK DRUG SUBSTANCE

DMF 274382013

STERLING BIOTECH LTDInactiveSIMVASTATIN AMMONIUM SALT (INTERMEDIATE)

DMF 308362016

STERLING BIOTECH LTDInactiveSIMVASTATIN USP

DMF 308372016

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

Products (5)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 11, 2007

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 11, 2007

#003 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 11, 2007

#004 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 11, 2007

#005 — 5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 14, 2009