Seysara (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — NDC: 16110-245-30 — 60 mg 30-count Bottle Label

60 mg 30-count Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 16110-246-30 — 100 mg 30-count Bottle Label

100 mg 30-count Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC: 16110-247-30 — 150 mg 30-count Bottle Label

150 mg 30-count Bottle Label
(click image for full-size original)

SEYSARA sarecycline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16110-245
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARECYCLINE HYDROCHLORIDE (SARECYCLINE) SARECYCLINE 60 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code S60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16110-245-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209521 01/04/2019
SEYSARA sarecycline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16110-246
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARECYCLINE HYDROCHLORIDE (SARECYCLINE) SARECYCLINE 100 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code S100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16110-246-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209521 01/04/2019
SEYSARA sarecycline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16110-247
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARECYCLINE HYDROCHLORIDE (SARECYCLINE) SARECYCLINE 150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code S150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16110-247-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209521 01/04/2019
Labeler — Almirall, LLC (605425912)

Revised: 08/2021 Almirall, LLC

Page 4 of 4 1 2 3 4

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