NDC | 65841-626-01, 65841-626-10, 65841-627-01, 65841-627-10, 65841-628-01, 65841-628-06 |
Set ID | 509d0eb2-b930-4836-9669-dbebf0ac4076 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Cadila Healthcare Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA077580 |
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
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 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-626, 65841-627, 65841-628) , MANUFACTURE(65841-626, 65841-627, 65841-628)