SPL Set ID: f1063950-b302-4898-81c2-b1626c9c16ef

1 drug(s) with this SPL Set ID

Open DailyMed details

Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
KVK-TECH, INC. 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: 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/300 mg contains: Hydrocodone Bitartrate. . . . . . . . 5 mg Acetaminophen. . . . . . . . . . . . . .300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . .7.5 mg Acetaminophen. . . . . . . . . . . . . . 300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . 10 mg Acetaminophen. . . . . . . . . . . . . .300 mg 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: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg: This product complies with USP dissolution test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg: This product complies with USP dissolution test 1. hbt-chemical-structure apap-chemical-structure

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