SPL Set ID: 62be4147-6a72-49e5-9338-10887c65a93a

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AMNEAL PHARMACEUTICALS OF NEW YORK LLC FDA Rx Only

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-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, USP, 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, USP ...... 5 mg Acetaminophen, USP ................. 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. This product complies with USP dissolution test 1. Structure Structure 2

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