Medicine
Balcoltra kit
Balcoltra kit is a prescription medicine containing Ethinyl estradiol and Levonorgestrel, marketed by Avion Pharmaceuticals, 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Ethinyl estradiol and Levonorgestrel
- Brand
- Balcoltra
- Dosage form
- Kit
- Packs
- 2 blister pack, 3 blister pack, 1 blister pack
- Marketing authorisation holder
- Avion Pharmaceuticals
- Manufacturer
- Avion Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). • Protect from light Keep out of the reach of children.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 April 2018
- Identifiers
- RxCUI 242297, 1999026, 2672922 +1DailyMed set ID 752ab698-4b48-4614-8016-d1d33ee7c007NDC 75854-602Application NDA208612
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 2 blister pack in 1 carton / 1 kit in 1 blister pack | 75854-602-02 | Avion Pharmaceuticals | 10 April 2018 |
| 3 blister pack in 1 carton / 1 kit in 1 blister pack | 75854-602-03 | Avion Pharmaceuticals | 10 April 2018 |
| 1 blister pack in 1 carton / 1 kit in 1 blister pack | 75854-602-28 | Avion Pharmaceuticals | 10 April 2018 |
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 10 May 1982 | 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
Alternatives
Other makers and brands of Ethinyl estradiol and Levonorgestrel kit.
Other strengths and forms of Ethinyl estradiol and Levonorgestrel
Clinical summary
Ethinyl estradiol and Levonorgestrel is a fixed-dose combination of an estrogen, a progestin and a progestin-containing intrauterine system indicated by females of reproductive potential to prevent pregnancy. MedsAcross supplies Ethinyl estradiol and Levonorgestrel 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 Ethinyl estradiol and LevonorgestrelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- levonorgestrel and ethinyl estradiol prescribing information (Acella Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Balcoltra kit 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.