Medicine
Acetic acid 20.65 mg/mL otic solution
Acetic acid 20.65 mg/mL otic solution is a generic prescription medicine for otic use, made by 3 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).
Key facts
- Active ingredient (INN)
- Acetic acid
- Brand
- Sold under the generic name
- Strength
- 20.65 mg/mL
- Dosage form
- Otic solution
- Route
- Otic
- Packs
- 1 bottle, 15 mL and 1 more
- Manufacturers
- NuCare Pharmaceuticals,IncA-S Medication SolutionsTruPharma
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G01AD02 Acetic acid
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 January 2010
- Identifiers
- RxCUI 197305DailyMed set ID c1c28375-9b03-4590-9d39-ab28403da93d, 0c5ebd59-0e98-4ea1-b279-9202a19f6dbf, 7470a1ed-bc00-cb52-e053-2a91aa0a5c7d +1NDC 50090-6527, 52817-816, 68071-1739 +1Application ANDA040607, NDA012179
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 15 mL in 1 bottle | 52817-816-15 | TruPharma | 1 June 2020 |
| 15 mL in 1 bottle | 68071-1739-5 | NuCare Pharmaceuticals,Inc | 27 August 2018 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 68071-2984-5 | NuCare Pharmaceuticals,Inc | 19 April 2023 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 50090-6527-0 | A-S Medication Solutions | 15 June 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 |
| 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 Acetic acid
Clinical summary
Acetic acid is a prescription medicine indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia-forming bacteria) in the management of patients. MedsAcross supplies Acetic acid 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 Acetic acidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Acetic Acid prescribing information (B. Braun Medical) · U.S. National Library of Medicine, DailyMed
Need Acetic acid 20.65 mg/mL otic 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.