Pill Identifier Information of paroxetine 20 MG (as paroxetine hydrochloride 22.76 MG ) Oral Tablet
Drug Information
paroxetine 20 MG (as paroxetine hydrochloride 22.76 MG ) Oral Tablet
| Imprint: | ZC;16 |
| Shape: | C48348 |
| Color: | C48325 |
| Ingredients: | Paroxetine |
| Size: | 8.00 |
| Score: | 2 |
| Rxtty: | SY |
| Author: | Cadila Healthcare Limited |
| Inactive Ingredients: | ANHYDROUS DIBASIC CALCIUM PHOSPHATE / ANHYDROUS LACTOSE / HYPROMELLOSES / MAGNESIUM STEARATE / POLYETHYLENE GLYCOL 6000 / SODIUM STARCH GLYCOLATE TYPE A POTATO / POVIDONE / TALC / TITANIUM DIOXIDE> |
Complete Information
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-097-06 in pack count of 30 tablets
Paroxetine Tablets USP, 10 mg
Rx only
30 tablets
NDC 65841-098-06 in pack count of 30 tablets
Paroxetine Tablets USP, 20 mg
Rx only
30 tablets
NDC 65841-099-06 in pack count of 30 tablets
Paroxetine Tablets USP, 30 mg
Rx only
30 tablets
NDC 65841-601-06 in pack count of 30 tablets
Paroxetine Tablets USP, 40 mg
Rx only
30 tablets
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INGREDIENTS AND APPEARANCE
PAROXETINEÂ
paroxetine hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-097 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  POVIDONE (UNII: FZ989GH94E)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZC;15 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-097-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 2 NDC:65841-097-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 3 NDC:65841-097-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 4 NDC:65841-097-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 5 NDC:65841-097-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007 PAROXETINEÂ
paroxetine hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-098 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE 20 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  POVIDONE (UNII: FZ989GH94E)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZC;16 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-098-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 2 NDC:65841-098-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 3 NDC:65841-098-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 4 NDC:65841-098-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 5 NDC:65841-098-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007 PAROXETINEÂ
paroxetine hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-099 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE 30 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  POVIDONE (UNII: FZ989GH94E)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ZC17 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-099-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 2 NDC:65841-099-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 3 NDC:65841-099-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 4 NDC:65841-099-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 5 NDC:65841-099-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007 PAROXETINEÂ
paroxetine hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-601 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H, PAROXETINE - UNII:41VRH5220H) PAROXETINE 40 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  HYPROMELLOSES (UNII: 3NXW29V3WO)  MAGNESIUM STEARATE (UNII: 70097M6I30)  POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  POVIDONE (UNII: FZ989GH94E)  TALC (UNII: 7SEV7J4R1U)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 11mm Flavor Imprint Code ZC18 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-601-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 2 NDC:65841-601-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 3 NDC:65841-601-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 4 NDC:65841-601-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 5 NDC:65841-601-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 04/13/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077584 04/13/2007 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-097, 65841-098, 65841-099, 65841-601) , MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 MANUFACTURE(65841-097, 65841-098, 65841-099, 65841-601)