SPL Set ID: 6e153073-ca78-481e-9e9c-0365ee3f3d59

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Hydrocodone Bitartrate, USP and Acetaminophen, USP is available in tablet form for oral administration. Hydrocodone bitartrate, USP is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. It is soluble in water, slightly soluble in alcohol, insoluble in ether and in chloroform. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: C 18 H 21 NO 3 • C 4 H 6 O 6 • 2 ½ H 2 O M.W. 494.50 Acetaminophen, USP, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available as follows: Strength Hydrocodone Bitartrate, USP Acetaminophen, USP 10 mg/325 mg 10 mg 325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Meets USP Dissolution Test 1. structure1 structure2

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