Label: DICLOFENAC SODIUM- declofenac sodium tablet, delayed release
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-686-30 - Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 16571-201
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 13, 2016
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- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- MEDICATION GUIDE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DICLOFENAC SODIUM
declofenac sodium tablet, delayed releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-686(NDC:16571-201) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 75 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) WATER (UNII: 059QF0KO0R) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color brown (Light Brown) Score no score Shape ROUND Size 10mm Flavor Imprint Code P;75 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-686-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077863 04/11/2016 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-686)
