NDC Code(s) : 51655-448-26, 51655-448-52
Packager : Northwind Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SimvastatinSimvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-448(NDC:70377-003)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SIMVASTATIN(UNII: AGG2FN16EV)
(SIMVASTATIN - UNII:AGG2FN16EV) 		SIMVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID(UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYANISOLE(UNII: REK4960K2U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ALCOHOL(UNII: 3K9958V90M)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POVIDONE(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color orange (orange to dark orange) Score no score
Shape OVAL (biconvex) Size 11 mm
Flavor Imprint Code B302;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51655-448-2690 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/10/2020
2NDC:51655-448-5230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product22/02/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078034 10/13/2020

LABELER - Northwind Pharmaceuticals, LLC(036986393)

REGISTRANT - Northwind Pharmaceuticals, LLC(036986393)

Establishment
Name Address ID/FEI Business Operations
Northwind Pharmaceuticals, LLC 036986393 repack(51655-448)

PRINCIPAL DISPLAY PANEL

NDC: 51655-448-26

Label