PAROXETINE: Package Insert and Label Information (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paroxetine Extended-Release Tablets USP, 12.5 mg

NDC 68180-647-06

BOTTLE LABEL — 30 TABLETS

12.5
(click image for full-size original)

Paroxetine Extended-Release Tablets USP, 25 mg

NDC 68180-646-06

BOTTLE LABEL — 30 TABLETS

25
(click image for full-size original)

Paroxetine Extended-Release Tablets USP, 37.5 mg

NDC 68180-645-06

BOTTLE LABEL — 30 TABLETS

37.5
(click image for full-size original)
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-647
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
D&C YELLOW NO. 10
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code L067
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-647-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68180-647-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68180-647-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:68180-647-03 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204134 03/06/2017
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-646
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
D&C RED NO. 30
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code L068
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-646-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68180-646-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68180-646-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:68180-646-03 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204134 03/06/2017
PAROXETINE paroxetine tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-645
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE (PAROXETINE) PAROXETINE 37.5 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FERROSOFERRIC OXIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color BLUE Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code L069
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-645-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68180-645-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68180-645-02 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204134 03/06/2017
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 MANUFACTURE (68180-645), MANUFACTURE (68180-646), MANUFACTURE (68180-647), PACK (68180-645), PACK (68180-646), PACK (68180-647)

Revised: 12/2019 Lupin Pharmaceuticals, Inc.

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