Medicine
Acetaminophen and Hydrocodone 325 mg/5 mg tablet
Acetaminophen and Hydrocodone 325 mg/5 mg tablet is a generic prescription medicine for oral use, made by 27 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store…
Key facts
- Active ingredient (INN)
- Acetaminophen and Hydrocodone
- Brand
- Sold under the generic name
- Strength
- 325 mg/5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 217 more
- Manufacturers
- Aurolife PharmaIndiaGranules IndiaIndiaLupinIndiaCamber PharmaceuticalsIndiaStrides PharmaIndiaSpecGxKVK-TechXLCare PharmaceuticalsAmneal Pharmaceuticals of New YorkCranbury Pharmaceuticals27 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 October 2000
- Identifiers
- RxCUI 857002, 856999, 857005 +4DailyMed set ID 36bf5e37-9202-4288-8354-9d123fb692d3, 26a2178e-e0e5-4d61-81fd-e30a3142f1f2, 53941807-072e-4783-819d-106ea904eda2 +37NDC 71335-2969, 43386-356, 55700-992 +37Application ANDA202214, ANDA206245, ANDA040409 +11
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 27 labelers. The register lists 220 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 13107-019-01 | Aurolife PharmaIndia | 11 April 2012 |
| 500 tablet in 1 bottle | 13107-019-05 | Aurolife PharmaIndia | 11 April 2012 |
| 30 tablet in 1 bottle | 13107-019-30 | Aurolife PharmaIndia | 11 April 2012 |
| 1000 tablet in 1 bottle | 13107-019-99 | Aurolife PharmaIndia | 11 April 2012 |
| 100 tablet in 1 bottle | 31722-996-01 | Camber PharmaceuticalsIndia | 8 November 2018 |
| 500 tablet in 1 bottle | 31722-996-05 | Camber PharmaceuticalsIndia | 8 November 2018 |
| 100 tablet in 1 bottle | 70010-672-01 | Granules IndiaIndia | 18 August 2021 |
| 500 tablet in 1 bottle | 70010-672-05 | Granules IndiaIndia | 18 August 2021 |
| 1000 tablet in 1 bottle | 70010-672-10 | Granules IndiaIndia | 6 June 2025 |
| 100 tablet in 1 bottle | 43386-356-01 | LupinIndia | 1 December 2016 |
| 500 tablet in 1 bottle | 43386-356-05 | LupinIndia | 1 December 2016 |
| 1000 tablet in 1 bottle | 43386-356-10 | LupinIndia | 1 December 2016 |
| 100 tablet in 1 bottle | 64380-440-01 | Strides PharmaIndia | 1 September 2025 |
| 100 tablet in 1 bottle | 72865-110-01 | XLCare Pharmaceuticals | 27 February 2020 |
| 500 tablet in 1 bottle | 72865-110-05 | XLCare Pharmaceuticals | 27 February 2020 |
| 100 tablet in 1 bottle | 72865-202-01 | XLCare Pharmaceuticals | 27 February 2020 |
| 500 tablet in 1 bottle | 72865-202-05 | XLCare Pharmaceuticals | 27 February 2020 |
| 100 tablet in 1 bottle | 53746-109-01 | Amneal Pharmaceuticals of New York | 18 January 2010 |
| 500 tablet in 1 bottle | 53746-109-05 | Amneal Pharmaceuticals of New York | 18 January 2010 |
| 1000 tablet in 1 bottle | 53746-109-10 | Amneal Pharmaceuticals of New York | 18 January 2010 |
| 100 tablet in 1 bottle, plastic | 27808-035-01 | Cranbury Pharmaceuticals | 6 October 2014 |
| 500 tablet in 1 bottle, plastic | 27808-035-02 | Cranbury Pharmaceuticals | 6 October 2014 |
| 1000 tablet in 1 bottle, plastic | 27808-035-03 | Cranbury Pharmaceuticals | 6 October 2014 |
| 100 tablet in 1 bottle, plastic | 64850-631-01 | Elite Laboratories | 16 November 2018 |
| 100 tablet in 1 bottle | 42806-111-01 | Epic Pharma | 2 April 2018 |
| 100 tablet in 1 bottle | 71930-019-12 | Eywa Pharma | 13 July 2018 |
| 1000 tablet in 1 bottle | 71930-019-13 | Eywa Pharma | 6 October 2022 |
| 500 tablet in 1 bottle | 71930-019-52 | Eywa Pharma | 13 July 2018 |
| 100 tablet in 1 bottle | 10702-189-01 | KVK-Tech | 22 June 2017 |
| 30 tablet in 1 bottle | 10702-189-03 | KVK-Tech | 22 June 2017 |
| 1000 tablet in 1 bottle | 10702-189-10 | KVK-Tech | 22 June 2017 |
| 500 tablet in 1 bottle | 10702-189-50 | KVK-Tech | 22 June 2017 |
| 100 tablet in 1 bottle | 42858-201-01 | Rhodes Pharmaceuticals | 12 April 2016 |
| 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 42858-201-10 | Rhodes Pharmaceuticals | 12 April 2016 |
| 500 tablet in 1 bottle | 42858-201-50 | Rhodes Pharmaceuticals | 12 April 2016 |
| 100 tablet in 1 bottle | 0406-0123-01 | SpecGx | 20 October 2000 |
| 500 tablet in 1 bottle | 0406-0123-05 | SpecGx | 20 October 2000 |
| 1000 tablet in 1 bottle | 0406-0123-10 | SpecGx | 20 October 2000 |
| 1 tablet in 1 blister pack | 0406-0123-23 | SpecGx | 20 October 2000 |
| 100 tablet in 1 blister pack | 0406-0123-62 | SpecGx | 20 October 2000 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | Approved | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Acetaminophen and Hydrocodone
Clinical summary
Acetaminophen and Hydrocodone is a fixed-dose combination medicine indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. MedsAcross supplies Acetaminophen and Hydrocodone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Acetaminophen and HydrocodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hydrocodone Bitartrate and Acetaminophen prescribing information (Granules India) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen and Hydrocodone 325 mg/5 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.