SPL Set ID: 136bbd47-7a54-493f-9158-a84d39221d6c
1 drug(s) with this SPL Set ID
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: 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: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg contains: Hydrocodone Bitartrate ...... 5 mg Acetaminophen ............... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ..................... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg contains: Hydrocodone Bitartrate .......... 10 mg Acetaminophen ..................... 325 mg In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, pregelatinized maize starch, povidone, silicified microcrystalline cellulose, and stearic acid. Meets USP Dissolution Test 1. hydroapap-structure-1 hydroapap-structure-2