Label: HALOPERIDOL tablet
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NDC Code(s):
65841-626-01,
65841-626-10,
65841-627-01,
65841-627-10, view more65841-628-01, 65841-628-06, 65841-837-01, 65841-837-10, 65841-837-30, 65841-837-77, 65841-838-01, 65841-838-10, 65841-838-30, 65841-838-77, 65841-839-01, 65841-839-10, 65841-839-30, 65841-839-77
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 30, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-837-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 0.5 mg
Rx only
100 Tablets
NDC 65841-838-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 1 mg
Rx only
100 Tablets
NDC 65841-839-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 2 mg
Rx only
100 Tablets
NDC 65841-626-01 in bottle of 100 Tablets
Haloperidol Tablets USP, 5 mg
Rx only
100 Tablets
NDC 65841-627-01 in bottles of 100 tablets
Haloperidol Tablets USP, 10 mg
Rx only
100 Tablets
NDC 65841-628-01 in bottles of 100 tablets
Haloperidol Tablets USP, 20 mg
Rx only
100 Tablets
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INGREDIENTS AND APPEARANCE
HALOPERIDOL
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-626 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) CALCIUM STEARATE (UNII: 776XM7047L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color GREEN (GREEN) Score 2 pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code ZC;07 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-626-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-626-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 01/03/2008 HALOPERIDOL
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-627 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 10 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color GREEN (LIGHT GREEN) Score 2 pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code ZC;08 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-627-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-627-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 01/03/2008 HALOPERIDOL
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-628 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 20 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color ORANGE (CORAL) Score 2 pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code ZC;09 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-628-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 2 NDC:65841-628-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/03/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 01/03/2008 HALOPERIDOL
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-837 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 0.5 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (OFF-WHITE) Score score with uneven pieces Shape ROUND Size 6mm Flavor Imprint Code 15;11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-837-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:65841-837-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:65841-837-77 10 in 1 CARTON 02/01/2023 3 NDC:65841-837-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 02/01/2023 HALOPERIDOL
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-838 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 1 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) ALUMINUM OXIDE (UNII: LMI26O6933) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color WHITE (PALE YELLOW) Score score with uneven pieces Shape ROUND Size 6mm Flavor Imprint Code 15;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-838-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:65841-838-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:65841-838-77 10 in 1 CARTON 02/01/2023 3 NDC:65841-838-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 02/01/2023 HALOPERIDOL
haloperidol tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-839 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HALOPERIDOL (UNII: J6292F8L3D) (HALOPERIDOL - UNII:J6292F8L3D) HALOPERIDOL 2 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) Product Characteristics Color PINK (Light Pink) Score score with uneven pieces Shape ROUND Size 7mm Flavor Imprint Code 15;13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-839-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 2 NDC:65841-839-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2023 3 NDC:65841-839-77 10 in 1 CARTON 02/01/2023 3 NDC:65841-839-30 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077580 02/01/2023 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-626, 65841-627, 65841-628, 65841-837, 65841-838, 65841-839) , MANUFACTURE(65841-626, 65841-627, 65841-628, 65841-837, 65841-838, 65841-839)