SPL Set ID: 5179d4ab-6d57-4613-84fc-de3f6edd6a53
1 drug(s) with this SPL Set ID
Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate, USP is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylm orphinan-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 •2½H 2 O M.W. = 494.49 Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C 8 H 9 NO 2 M.W. = 151.16 Each hydrocodone bitartrate and acetaminophen tablets USP, 5 mg/325 mg contains: Hydrocodone Bitartrate ...... 5 mg Acetaminophen ................. 325 mg Each hydrocodone bitartrate and acetaminophen tablets USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ................ 325 mg Each hydrocodone bitartrate and acetaminophen tablets USP, 10 mg/325 mg contains: Hydrocodone Bitartrate .......... 10 mg Acetaminophen .............. 325 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. In addition, the 5 mg/325 mg strength contains sugar spheres which are composed of starch derived from corn, sugar, and FD&C Yellow #6. The 7.5 mg/325 mg strength contains FD&C Yellow #6 Aluminum Lake. The 10 mg/325 mg strength contains FD&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 2. hydrocodone-structure-formula.jpg acetaminophen-structure-formula.jpg