CARBIDOPA AND LEVODOPA tablet
Carbidopa and Levodopa by
Drug Labeling and Warnings
Carbidopa and Levodopa by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 70771-1694-1
Carbidopa and Levodopa Tablets, USP 10 mg/100 mg
100 Tablets
Rx only
NDC: 70771-1695-1
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg
100 Tablets
Rx only
NDC: 70771-1696-1
Carbidopa and Levodopa Tablets, USP 25 mg/250 mg
100 Tablets
Rx only
-
INGREDIENTS AND APPEARANCE
CARBIDOPA AND LEVODOPA
carbidopa and levodopa tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1694 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS 10 mg LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA 100 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BLUE (light blue) Score 2 pieces Shape ROUND (round) Size 8mm Flavor Imprint Code 1721 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1694-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 2 NDC: 70771-1694-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 3 NDC: 70771-1694-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215999 08/24/2024 CARBIDOPA AND LEVODOPA
carbidopa and levodopa tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1695 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS 25 mg LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA 100 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (light yellow) Score 2 pieces Shape ROUND (round) Size 8mm Flavor Imprint Code 1722 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1695-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 2 NDC: 70771-1695-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 3 NDC: 70771-1695-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215999 08/24/2024 CARBIDOPA AND LEVODOPA
carbidopa and levodopa tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1696 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBIDOPA (UNII: MNX7R8C5VO) (CARBIDOPA ANHYDROUS - UNII:KR87B45RGH) CARBIDOPA ANHYDROUS 25 mg LEVODOPA (UNII: 46627O600J) (LEVODOPA - UNII:46627O600J) LEVODOPA 250 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BLUE (light blue) Score 2 pieces Shape ROUND (round) Size 10mm Flavor Imprint Code 1723 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1696-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 2 NDC: 70771-1696-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 3 NDC: 70771-1696-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215999 08/24/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1694, 70771-1695, 70771-1696) , MANUFACTURE(70771-1694, 70771-1695, 70771-1696)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.