Pill Identifier Information of Promethazine Hydrochloride 12.5 MG Oral Tablet
Drug Information
Promethazine Hydrochloride 12.5 MG Oral Tablet
| Imprint: | ZC;01 |
| Shape: | C48348 |
| Color: | C48325 |
| Ingredients: | Promethazine |
| Size: | 6.00 |
| Score: | 2 |
| Rxtty: | SCD |
| Author: | Cadila Healthcare Limited |
| Inactive Ingredients: | HYDROXYPROPYL CELLULOSE / LACTOSE MONOHYDRATE / MAGNESIUM STEARATE / HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED> |
Complete Information
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-040-01 in bottle of 100 tablets
Promethazine Hydrochloride Tablets USP, 12.5 mg
Rx only
100 tablets
NDC 65841-041-01 in bottle of 100 tablets
Promethazine Hydrochloride Tablets USP, 25 mg
Rx only
100 tablets
NDC 65841-042-01 in bottle of 100 tablets
Promethazine Hydrochloride Tablets USP, 50 mg
Rx only
100 tablets
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INGREDIENTS AND APPEARANCE
PROMETHAZINE HYDROCHLORIDEÂ
promethazine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-040 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE 12.5 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  MAGNESIUM STEARATE (UNII: 70097M6I30)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZC;01 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-040-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 2 NDC:65841-040-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 3 NDC:65841-040-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040596 12/14/2005 PROMETHAZINE HYDROCHLORIDEÂ
promethazine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-041 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  MAGNESIUM STEARATE (UNII: 70097M6I30)  HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 4 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code Z;C;0;2 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-041-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 2 NDC:65841-041-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 3 NDC:65841-041-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040596 12/14/2005 PROMETHAZINE HYDROCHLORIDEÂ
promethazine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-042 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  MAGNESIUM STEARATE (UNII: 70097M6I30)  HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ZC03 Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-042-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 2 NDC:65841-042-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 3 NDC:65841-042-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040596 12/14/2005 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-040, 65841-041, 65841-042) , MANUFACTURE(65841-040, 65841-041, 65841-042) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-040, 65841-041, 65841-042) , MANUFACTURE(65841-040, 65841-041, 65841-042)