Hydrocodone bitartrate + Acetaminophen tablets bulk supplier for pharma manufacturers

Hydrocodone Bitartrate + Acetaminophen Tablets Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: hydrocodone / acetaminophen: 5 mg/325 mg, 7.5 / 325 mg, 10 mg / 325 mg

Reference Brands: Vicodin (US)

Category: Analgesic

Hydrocodone + Acetaminophen combine activate opioid receptors, reducing pain signals and perception. Acetaminophen enhances analgesia and fever reduction. Benefits include effective relief from moderate to severe pain, improved comfort, and rapid onset. It’s frequently prescribed post-surgery or injury, but requires careful use due to dependence and overdose risks.

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Product Description:

Hydrocodone + Acetaminophen tablets are approved in the US for moderate to severe pain, regulated by the DEA and FDA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the EU, such combination products are regulated by EMA, requiring comprehensive dossiers and pharmacovigilance plans. Due to high addiction potential, strict controls, prescribing regulations, and monitoring are enforced in both regions. We support efficient market access, ensuring adherence to European and US standards for safe, effective use of opioid combination therapy while navigating complex regulatory pathways seamlessly.

Controlled medicine — licensed supply only

This product is controlled in many countries under narcotic, psychotropic, precursor or other drug laws, which vary by country. We supply only licensed buyers holding any import certificate, permit or authorisation their national authority requires, and the Indian manufacturer or exporter must hold the required licences. In India, each export of a narcotic drug or psychotropic substance needs an export authorisation, and export of ephedrine, pseudoephedrine or their preparations a No Objection Certificate, from the Narcotics Commissioner (Central Bureau of Narcotics). We verify permits before quoting.

Hydrocodone Bitartrate + Acetaminophen Tablets — third party manufacturing & bulk supply

Hydrocodone Bitartrate + Acetaminophen Tablets is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Hydrocodone Bitartrate + Acetaminophen Tablets is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Hydrocodone Bitartrate + Acetaminophen Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Hydrocodone Bitartrate + Acetaminophen is used for the relief of moderate to moderately severe pain. Hydrocodone works as an opioid analgesic, while acetaminophen enhances the pain-relieving effect and helps reduce fever.

It is made from two active ingredients: hydrocodone bitartrate, a semi-synthetic opioid derived from codeine, and acetaminophen (paracetamol), a widely used analgesic and antipyretic.

Common trade names include Vicodin, Norco, and Lortab.

Vicodin and related brands have been marketed by companies such as Abbott Laboratories and UCB Pharma, while many manufacturers in the USA produce generic versions.

The generic name is hydrocodone bitartrate and acetaminophen.

Well-known brand names include Vicodin, Norco, and Lortab.

It is primarily manufactured in the USA by several branded and generic pharmaceutical companies, as this combination is mainly regulated and marketed in the US market.