Haloperidol Tablets, Usp

SPL v8

SPL

SPL Set ID 509d0eb2-b930-4836-9669-dbebf0ac4076

Route

ORAL

Published

Effective Date 2023-01-30

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Haloperidol (5 mg)

Inactive Ingredients

Aluminum Oxide Calcium Stearate D&c Yellow No. 10 Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Povidone K30 Sodium Starch Glycolate Type A Potato Starch, Corn D&c Red No. 27 Aluminum Lake Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose 102 Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 15;13 Shape: oval Shape: round Color: green Color: orange Color: white Color: pink Size: 10 mm Size: 6 mm Size: 7 mm Score: 2

Marketing Status

ANDA Active Since 2023-02-01

Description

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 R x only 100 Tablets NDC 65841-628-01 in bottles of 100 tablets Haloperidol Tablets USP, 20 mg R x only 100 Tablets

Medication Information

Description

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

R_x only

100 Tablets

NDC 65841-628-01 in bottles of 100 tablets

Haloperidol Tablets USP, 20 mg

R_x only

100 Tablets

Structured Label Content

Package Label.principal Display Panel (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

R_x only

100 Tablets

NDC 65841-628-01 in bottles of 100 tablets

Haloperidol Tablets USP, 20 mg

R_x only

100 Tablets

Advanced Ingredient Data

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{"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HALOPERIDOL", "unii": "J6292F8L3D", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 102", "unii": "PNR0YF693Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HALOPERIDOL", "unii": "J6292F8L3D", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE 102", "unii": "PNR0YF693Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", 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Raw Label Data

All Sections (JSON)

{"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 R x only 100 Tablets NDC 65841-628-01 in bottles of 100 tablets Haloperidol Tablets USP, 20 mg R x only 100 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:58.960378 · Updated: 2026-03-14T22:18:18.443233