SPL Set ID: abc33718-4e88-43ea-9ffa-2b04ffc812ef

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Ibuprofen HYDROCODONE BITARTRATE AND IBUPROFEN
AMNEAL PHARMACEUTICALS OF NEW YORK LLC FDA Rx Only

Each hydrocodone bitartrate and ibuprofen tablet contains either: Hydrocodone Bitartrate, USP 2.5 mg, 5 mg, 7.5 mg, or 10 mg and Ibuprofen, USP 200 mg Hydrocodone bitartrate and ibuprofen tablets are supplied in a fixed combination tablet form for oral administration. Hydrocodone bitartrate and ibuprofen tablets combine the opioid agonist, hydrocodone bitartrate, USP, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen, USP. Hydrocodone bitartrate, USP is a semisynthetic opioid agonist. Its chemical name is: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C 18 H 21 NO 3 •C 4 H 6 O 6 •2½H 2 O, and the molecular weight is 494.50. Its structural formula is: Ibuprofen, USP is a nonsteroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is: (±)-2-( p -isobutylphenyl) propionic acid. Its chemical formula is: C 13 H 18 O 2 , and the molecular weight is: 206.29. Its structural formula is: Inactive ingredients in hydrocodone bitartrate and ibuprofen 2.5 mg/200 mg, 5 mg/200 mg and 7.5 mg/200 mg tablets include: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch and titanium dioxide. Inactive ingredients in hydrocodone bitartrate and ibuprofen 10 mg/200 mg tablets include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch, titanium dioxide, triacetin and D&C Yellow #10 Aluminum Lake. 893afda7-figure-01 893afda7-figure-02

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