Medicine
Sodium bicarbonate 12600 mg/1000 mL injection
Sodium bicarbonate 12600 mg/1000 mL injection is a generic prescription medicine for intravenous 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
Protect from freezing. Store at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Sodium bicarbonate
- Brand
- Sold under the generic name
- Strength
- 12600 mg/1000 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 6 pouches of 1000 mL, 10 bags of 1000 mL
- Manufacturers
- Amneal PharmaceuticalsBaxter Healthcare
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B05CB04 Sodium bicarbonate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 July 2026
- Identifiers
- RxCUI 2747138DailyMed set ID ac91e834-e693-43a2-829b-56793453e8cc, b50c858a-00c8-4cb2-ad73-8797f19e656dNDC 80830-2613, 0338-0822Application NDA220790, NDA218524
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 |
|---|---|---|---|
| 6 pouch in 1 carton / 1 bag in 1 pouch / 1000 mL in 1 bag | 80830-2613-2 | Amneal Pharmaceuticals | 13 July 2026 |
| 10 bag in 1 carton / 1000 mL in 1 bag | 0338-0822-10 | Baxter Healthcare | 14 August 2026 |
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 | First approved 3 June 1986 | 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 Sodium bicarbonate
Clinical summary
Sodium bicarbonate is an osmotic laxative indicated to raise plasma pH in adults and pediatric patients with clinically significant metabolic acidosis, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Sodium bicarbonate 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 Sodium bicarbonateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sodium Bicarbonate prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Sodium bicarbonate 12600 mg/1000 mL injection 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.