Label: PRAMIPEXOLE DIHYDROCHLORIDE tablet
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NDC Code(s):
65841-734-05,
65841-734-10,
65841-734-16,
65841-735-05, view more65841-735-10, 65841-735-16, 65841-736-05, 65841-736-10, 65841-736-16, 65841-737-05, 65841-737-10, 65841-737-16, 65841-738-05, 65841-738-10, 65841-738-16, 65841-844-05, 65841-844-10, 65841-844-16
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 16, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-734-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 0.125 mg
Rx only
1000 tablets
NDC 65841-735-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 0.25 mg
Rx only
1000 tablets
NDC 65841-736-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 0.5 mg
Rx only
1000 tablets
NDC 65841-737-10 in bottle of 1000 tablets
Pramipexole Dihydrochloride Tablets, 1 mg
Rx only
1000 tablets
NDC 65841-738-16 in bottle of 90 tablets
Pramipexole Dihydrochloride Tablets, 1.5 mg
Rx only
90 tablets
NDC 65841-844-16 in bottle of 90 tablets
Pramipexole Dihydrochloride Tablets, 0.75 mg
Rx only
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INGREDIENTS AND APPEARANCE
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-734 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color PINK (PINK) Score no score Shape CAPSULE (CAPSULE) Size 7mm Flavor Imprint Code P1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-734-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 2 NDC:65841-734-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 3 NDC:65841-734-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078920 07/10/2010 PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-735 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 0.25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color BLUE (PALE BLUE) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code P2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-735-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 2 NDC:65841-735-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 3 NDC:65841-735-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078920 07/10/2010 PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-736 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 0.5 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color PURPLE (LAVENDER) Score 2 pieces Shape CAPSULE (CAPSULE) Size 8mm Flavor Imprint Code P;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-736-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 2 NDC:65841-736-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 3 NDC:65841-736-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078920 07/10/2010 PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-737 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 1 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) FERRIC OXIDE RED (UNII: 1K09F3G675) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color ORANGE (LIGHT PEACH TO PEACH) Score 2 pieces Shape ROUND (ROUND) Size 6mm Flavor Imprint Code P4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-737-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 2 NDC:65841-737-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 3 NDC:65841-737-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078920 07/10/2010 PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-738 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code P5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-738-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 2 NDC:65841-738-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 3 NDC:65841-738-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078920 07/10/2010 PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-844 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T) PRAMIPEXOLE DIHYDROCHLORIDE 0.75 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (ROUND) Size 7mm Flavor Imprint Code P5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-844-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/23/2022 2 NDC:65841-844-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2022 3 NDC:65841-844-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078920 11/23/2022 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-734, 65841-735, 65841-736, 65841-737, 65841-738, 65841-844) , MANUFACTURE(65841-734, 65841-735, 65841-736, 65841-737, 65841-738, 65841-844)