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

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

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

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

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

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.