Medicine
Acetaminophen and Hydrocodone 300 mg/5 mg tablet
Acetaminophen and Hydrocodone 300 mg/5 mg tablet is a generic prescription medicine for oral use, made by 7 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 20°C to 25°C (68°F to 77°F). Store hydrocodone bitartrate and…
Key facts
- Active ingredient (INN)
- Acetaminophen and Hydrocodone
- Brand
- Sold under the generic name
- Strength
- 300 mg/5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 18 more
- Manufacturers
- Aurolife PharmaIndiaLupinIndiaBryant Ranch PrepackKVK-TechCranbury PharmaceuticalsSpecGxEywa Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°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
- 6 May 2015
- Identifiers
- RxCUI 856980, 856987, 856992 +3DailyMed set ID f1063950-b302-4898-81c2-b1626c9c16ef, 2f6d0712-e756-49f2-a6b8-bbd160a454c4, d621b526-4d9a-48a9-9a3e-d29d6aea2f31 +8NDC 10702-192, 63629-1177, 0406-0376 +8Application ANDA209036, ANDA207509, ANDA206718 +3
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 13107-211-01 | Aurolife PharmaIndia | 6 May 2015 |
| 500 tablet in 1 bottle | 13107-211-05 | Aurolife PharmaIndia | 6 May 2015 |
| 30 tablet in 1 bottle | 13107-211-30 | Aurolife PharmaIndia | 6 May 2015 |
| 1000 tablet in 1 bottle | 13107-211-99 | Aurolife PharmaIndia | 6 May 2015 |
| 100 tablet in 1 bottle | 43386-351-01 | LupinIndia | 14 November 2016 |
| 500 tablet in 1 bottle | 43386-351-05 | LupinIndia | 14 November 2016 |
| 100 tablet in 1 bottle, plastic | 27808-114-01 | Cranbury Pharmaceuticals | 7 April 2016 |
| 500 tablet in 1 bottle | 27808-114-02 | Cranbury Pharmaceuticals | 7 April 2016 |
| 100 tablet in 1 bottle | 71930-042-12 | Eywa Pharma | 17 June 2019 |
| 100 tablet in 1 bottle | 10702-192-01 | KVK-Tech | 22 June 2017 |
| 30 tablet in 1 bottle | 10702-192-03 | KVK-Tech | 22 June 2017 |
| 1000 tablet in 1 bottle | 10702-192-10 | KVK-Tech | 22 June 2017 |
| 500 tablet in 1 bottle | 10702-192-50 | KVK-Tech | 22 June 2017 |
| 100 tablet in 1 bottle | 0406-0376-01 | SpecGx | 31 March 2017 |
| 500 tablet in 1 bottle | 0406-0376-05 | SpecGx | 31 March 2017 |
| 100 tablet in 1 bottle | 63629-1177-1 | Bryant Ranch Prepack | 17 June 2019 |
| 500 tablet in 1 bottle | 63629-1179-1 | Bryant Ranch Prepack | 1 September 2020 |
| 100 tablet in 1 bottle, plastic | 63629-2308-1 | Bryant Ranch Prepack | 7 April 2016 |
| 100 tablet in 1 bottle, plastic | 72162-1287-1 | Bryant Ranch Prepack | 7 April 2016 |
| 100 tablet in 1 bottle | 72162-1996-1 | Bryant Ranch Prepack | 17 June 2019 |
| 500 tablet in 1 bottle | 72162-1996-5 | Bryant Ranch Prepack | 17 June 2019 |
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 300 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.