SPL Set ID: 26a2178e-e0e5-4d61-81fd-e30a3142f1f2

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
LUPIN PHARMACEUTICALS,INC. FDA Rx Only

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are 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, 5 mg/325 mg contains: Hydrocodone Bitartrate ...... 5 mg Acetaminophen................. 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ................ 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains: Hydrocodone Bitartrate .......... 10 mg Acetaminophen.............. 325 mg In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, stearic acid, magnesium stearate, corn starch, pregelatinized starch and povidone. Meets USP Dissolution Test 2. Hydrocodone APAP

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