Label: LOSARTAN POTASSIUM tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-461-30 - Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 13668-113
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 3, 2015
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- Description
- Clinical Pharmacology
- Indications and Usage
- Contraindications
- Warnings
- Precautions
- Adverse Reactions
- Overdosage
- Dosage and Administration
- Package Label
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INGREDIENTS AND APPEARANCE
LOSARTAN POTASSIUM
losartan potassium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-461(NDC:13668-113) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM 25 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white to off-white) Score no score Shape OVAL (oval shaped, biconvex) Size 8mm Flavor Imprint Code 25;113 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-461-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/03/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090467 12/03/2015 Labeler - DirectRX (079254320) Establishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-461)