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Product NDC Code | 65841-042 | ||||||||
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Drug Name | Promethazine hydrochloride |
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Type | Generic | ||||||||
Pharm Class | Phenothiazine [EPC], Phenothiazines [CS] |
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Active Ingredients |
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Route | ORAL | ||||||||
Dosage Form | TABLET | ||||||||
RxCUI drug identifier | 992438, 992447, 992475 |
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Application Number | ANDA040596 | ||||||||
Labeler Name | Zydus Lifesciences Limited | ||||||||
Packages |
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Check if available Online | Get Medication Prices online with Discount |
Spl product data elements
Usually a list of ingredients in a drug product.Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED WHITE TO OFF-WHITE ROUND ZC;01 Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED WHITE TO OFF-WHITE ROUND Z;C;0;2 Promethazine Hydrochloride Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE PROMETHAZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC03
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-040-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 12.5 mg R x only 100 tablets NDC 65841-041-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 25 mg R x only 100 tablets NDC 65841-042-01 in bottle of 100 tablets Promethazine Hydrochloride Tablets USP, 50 mg R x only 100 tablets Promethzine Tablets, 12.5 mg Promethazine Tablets, 25 mg Promethazine Tablets, 50 mg
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API