SPIRONOLACTONE (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Patients who receive spironolactone tablets should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.

Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Manufactured by:
Frontida BioPharm, Inc.
Philadelphia, PA 19124.
Rev. 02, August 2020

Spironolactone Tablets 25mg

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Spironolactone Tablets 50mg

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Spironolactone Tablets 100mg

S:\exRanbaxy\SAN-Reg\Regulatory\spl\Deepa\2020\Spironolactone Northstar\20200424_2aead427-3e25-4a87-a858-f2bd7642baf5\SpironolactoneNS-06.jpg
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SPIRONOLACTONE
spironolactone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-084
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
POVIDONE, UNSPECIFIED
DOCUSATE SODIUM
SODIUM BENZOATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor PEPPERMINT Imprint Code MP;35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-084-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:16714-084-02 500 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:16714-084-03 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089424 04/23/2020
SPIRONOLACTONE
spironolactone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-085
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
DOCUSATE SODIUM
SODIUM BENZOATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor PEPPERMINT Imprint Code MP;542
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-085-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:16714-085-02 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089424 04/23/2020
SPIRONOLACTONE
spironolactone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-086
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPIRONOLACTONE (SPIRONOLACTONE) SPIRONOLACTONE 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
DOCUSATE SODIUM
SODIUM BENZOATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19mm
Flavor PEPPERMINT Imprint Code MP;303
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-086-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:16714-086-02 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:16714-086-03 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:16714-086-04 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089424 04/23/2020
Labeler — NorthStar Rx LLC (830546433)
Establishment
Name Address ID/FEI Operations
Frontida BioPharm, Inc. 080243260 MANUFACTURE (16714-084), MANUFACTURE (16714-085), MANUFACTURE (16714-086)

Revised: 09/2020 NorthStar Rx LLC

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