Sular

SULAR (nisoldipine) Extended Release TabletsFor Oral Use

Approved

Approval ID

589157fa-d129-4de3-be3d-e0e1c22c5873

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 24, 2023

Manufacturers

FDA

Covis Pharma US, Inc

DUNS: 118094829

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

nisoldipine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70515-500

Application NumberNDA020356

Product Classification

Marketing Category

C73594

Generic Name

nisoldipine

Product Specifications

Route of AdministrationORAL

Effective DateJuly 26, 2017

FDA Product Classification

INGREDIENTS (15)

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

NISOLDIPINEActive

Quantity: 8.5 mg in 1 1

Code: 4I8HAB65SZ

Classification: ACTIB

HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive

Code: 87Y6436BKR

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IE

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

nisoldipine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70515-503

Application NumberNDA020356

Product Classification

Marketing Category

C73594

Generic Name

nisoldipine

Product Specifications

Route of AdministrationORAL

Effective DateJuly 26, 2017

FDA Product Classification

INGREDIENTS (15)

NISOLDIPINEActive

Quantity: 34 mg in 1 1

Code: 4I8HAB65SZ

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive

Code: 87Y6436BKR

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IE

Classification: IACT

nisoldipine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70515-501

Application NumberNDA020356

Product Classification

Marketing Category

C73594

Generic Name

nisoldipine

Product Specifications

Route of AdministrationORAL

Effective DateJuly 26, 2017

FDA Product Classification

INGREDIENTS (16)

NISOLDIPINEActive

Quantity: 17 mg in 1 1

Code: 4I8HAB65SZ

Classification: ACTIB

HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive

Code: 87Y6436BKR

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE, UNSPECIFIED FORMInactive

Code: J2B2A4N98G

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1M

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IE

Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/13/2019

PRINCIPAL DISPLAY PANEL - 34 mg Carton

Principal Display Panel - 34 mg Carton

34 mg Carton

NDC 70515-503-10

100 Tablets

Sular**®******
(nisoldipine)
Extended Release
Tablets

34 mg

Rx only

See package insert for full prescribing
information.

COVIS

Store at 20°-25°C (68°-77°F); excursions
permitted between 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature].
Protect from light and moisture. Dispense
in USP tight, light-resistant container.

See package insert for full prescribing
information.

Manufactured for:
Covis Pharma
Zug, 6300 Switzerland

Made in Germany

GTIN: XXXXXXXXXXXXXX
S/N: XXXXXXXXXXXX
EXP: MMM/YYYY
LOT: XXXXXXX

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/26/2017

HOW SUPPLIED

SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:

Strength	Color	Markings
8.5 mg	Oyster	SCI 500
17 mg	Yellow Cream	SCI 501
34 mg	Burnt Orange	SCI 503

SULAR Tablets are supplied in bottles of 100:

NDC Code	Strength
70515-500-10	8.5 mg
70515-501-10	17 mg
70515-503-10	34 mg

Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.

Rx only

Manufactured for:
Covis Pharma
Zug, 6300 Switzerland

Made in Germany

Rev 07/17

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Sular

Products 3

nisoldipine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

nisoldipine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

nisoldipine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 34 mg Carton

HOW SUPPLIED SECTION

HOW SUPPLIED

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