Label: LEVOTHYROXINE SODIUM tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-403-30 - Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 0527-1342
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application Authorized Generic
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
LEVOTHYROXINE SODIUM
levothyroxine sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-403(NDC:0527-1342) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOTHYROXINE SODIUM (UNII: 9J765S329G) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE SODIUM ANHYDROUS 0.05 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ACACIA (UNII: 5C5403N26O) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) LACTOSE (UNII: J2B2A4N98G) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code JSP;514 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-403-30 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 NDA authorized generic NDA021210 12/02/2015 Labeler - DirectRX (079254320) Establishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-403)
