Medicine
Acetaminophen and Codeine 120 mg/12 mg per 5 mL oral solution
Acetaminophen and Codeine 120 mg/12 mg per 5 mL oral solution is a generic prescription medicine for oral use, made by 2 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° to 25°C (68° to 77°F). Store acetaminophen and codeine phosphate…
Key facts
- Active ingredient (INN)
- Acetaminophen and Codeine
- Brand
- Sold under the generic name
- Strength
- 120 mg/12 mg per 5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 40 trays, 118 mL, 473 mL and 1 more
- Manufacturers
- Genus LifesciencesPAI Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store acetaminophen and codeine phosphate oral solution securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CV
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 August 1981
- Identifiers
- RxCUI 993755DailyMed set ID 95ac6875-6b14-4cde-8efb-80704e39b8d8, 95a5d638-3072-4c37-a4cd-f8550328e2c6NDC 0121-1008, 64950-374, 0121-0504Application ANDA087508
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 |
|---|---|---|---|
| 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-0504-40 | PAI Pharma | 21 August 1981 |
| 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 12.5 mL in 1 cup, unit-dose | 0121-1008-40 | PAI Pharma | 21 August 1981 |
| 118 mL in 1 bottle, plastic | 64950-374-04 | Genus Lifesciences | 10 August 2023 |
| 473 mL in 1 bottle, plastic | 64950-374-16 | Genus Lifesciences | 10 August 2023 |
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 Codeine
Clinical summary
Acetaminophen and Codeine is a fixed-dose combination medicine indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. MedsAcross supplies Acetaminophen and Codeine 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 CodeineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ACETAMINOPHEN AND CODEINE PHOSPHATE prescribing information (Eywa Pharma) · U.S. National Library of Medicine, DailyMed
Need Acetaminophen and Codeine 120 mg/12 mg per 5 mL oral solution 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.