Sertraline Hydrochloride (Page 9 of 9)

Package/Label Display Panel

RANBAXY

NDC 63304-164-03

SERTRALINE HYDROCHLORIDE Tablets

25 mg*

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE SEPARATELY

Rx only 10 Tablets

25 mg Bottle Label
(click image for full-size original)

Package/Label Display Panel

RANBAXY

NDC 63304-165-03

SERTRALINE HYDROCHLORIDE Tablets

50 mg*

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE SEPARATELY

Rx only 10 Tablets

50 mg Bottle Label
(click image for full-size original)

Package/Label Display Panel

RANBAXY

NDC 63304-166-03

SERTRALINE HYDROCHLORIDE Tablets

100 mg*

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE SEPARATELY

Rx only 10 Tablets

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

Package/Label Display Panel

RANBAXY

NDC 63304-167-03

SERTRALINE HYDROCHLORIDE Tablets

150 mg*

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE SEPARATELY

Rx only 10 Tablets

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

Package/Label Display Panel

RANBAXY

NDC 63304-168-03

SERTRALINE HYDROCHLORIDE Tablets

200 mg*

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE SEPARATELY

Rx only 10 Tablets

200 mg Bottle Label
(click image for full-size original)
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 11mm
Flavor Imprint Code RE16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-164-03 10 TABLET, COATED in 1 BOTTLE None
2 NDC:63304-164-30 30 TABLET, COATED in 1 BOTTLE None
3 NDC:63304-164-50 50 TABLET, COATED in 1 BOTTLE None
4 NDC:63304-164-52 2500 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077977 02/06/2007
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 11mm
Flavor Imprint Code RX165
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-165-03 10 TABLET, COATED in 1 BOTTLE None
2 NDC:63304-165-30 30 TABLET, COATED in 1 BOTTLE None
3 NDC:63304-165-01 100 TABLET, COATED in 1 BOTTLE None
4 NDC:63304-165-05 500 TABLET, COATED in 1 BOTTLE None
5 NDC:63304-165-52 2500 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077977 02/06/2007
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-166
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 100 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 11mm
Flavor Imprint Code RX166
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-166-03 10 TABLET, COATED in 1 BOTTLE None
2 NDC:63304-166-30 30 TABLET, COATED in 1 BOTTLE None
3 NDC:63304-166-01 100 TABLET, COATED in 1 BOTTLE None
4 NDC:63304-166-05 500 TABLET, COATED in 1 BOTTLE None
5 NDC:63304-166-52 2500 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077977 02/06/2007
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-167
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 150 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 11mm
Flavor Imprint Code RX167
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-167-03 10 TABLET, COATED in 1 BOTTLE None
2 NDC:63304-167-10 1000 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077977 02/06/2007
SERTRALINE HYDROCHLORIDE
sertraline hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-168
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 11mm
Flavor Imprint Code RX168
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-168-03 10 TABLET, COATED in 1 BOTTLE None
2 NDC:63304-168-10 1000 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077977 02/06/2007
Labeler — Ranbaxy Pharmaceuticals Inc. (937890044)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 051565745 MANUFACTURE (63304-164), MANUFACTURE (63304-165), MANUFACTURE (63304-166), MANUFACTURE (63304-167), MANUFACTURE (63304-168)

Revised: 01/2016 Ranbaxy Pharmaceuticals Inc.

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