SPL Set ID: f0e66441-668a-7ab8-e053-2995a90aba4f

1 drug(s) with this SPL Set ID

Open DailyMed details

Hydrocodone/APAP HYDROCODONE APAP
DIRECT_RX FDA Rx Only

Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate 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-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: [Chemical Structure of Hydrocodone Bitartrate] 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: [Chemical Structure of Acetaminophen] Each Hydrocodone Bitartrate and Acetaminophen Tablet USP contains: Tablet Hydrocodone Bitartrate USP Acetaminophen USP 5 mg/325 mg 5 mg 325 mg 7.5 mg/325 mg 7.5 mg 325 mg 10 mg/325 mg 10 mg 325 mg In addition each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, and stearic acid. Meets USP Dissolution Test 1.

← Back to search