United States· US:70700-303_35d8f763-8f98-f5ea-fae8-1367b638e82c
ABIGALE LO
A medicinal product containing estradiol; norethindrone acetate, registered in United States by Xiromed LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Manufacturer
- Xiromed LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1170700303853 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACK
- ndc1170700-303-85
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Estradiol; norethindrone acetate in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaACTIVELLE LDNOVO NORDISK CANADA INC
- United KingdomClimesse tabletsDowelhurst Ltd
- NorwayActivelleNovo Nordisk A/S
- SwitzerlandActivelle
- SwedenActivelle 1 mg/0,5 mg Filmdragerad tablettNovo Nordisk A/S
- PolandActivelleNovo Nordisk A/S
- IcelandActivelleNovo Nordisk A/S*
- SpainACTIVELLE 1 mg/0,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULAIsdin S.A.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Activelle, Kliogest
- Belgium · Activelle, Activelle Minor
- Bulgaria · Активел, Трисеквенс
- Cyprus · Trisequens
- Czechia · Activelle, Kliogest
- Germany · Activelle, Cliovelle
- Denmark · Activelle, Activelle Low
- Estonia · Activelle, Eviana
- Spain · Activelle, Duofemme
- Finland · Activelle, Cliovelle
- France · Activelle, Kliogest
- Greece · Trisequens
- Croatia · Activelle, Novofem
- Hungary · Activelle, Kliogest
- Ireland · Activelle, Kliogest
- Iceland · Activelle, Activelle Low
- Italy · Activelle
- Lithuania · Activelle, Kliogest
- Luxembourg · Activelle, Activelle Minor
- Latvia · Activelle, Kliogest
- Netherlands · Activelle
- Norway · Activelle, Cliovelle
- Poland · Cliovelle, Kliogest
- Portugal · Activelle, Kliogest
- Sweden · Activelle, Cliovelle
- Slovenia · Activelle, Kliogest
- Slovakia · Activelle, Novofem
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/91dac498-0ee9-433a-a307-e9fb83e5adf5 GET /v1/drugs/91dac498-0ee9-433a-a307-e9fb83e5adf5?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": ".5; .1",
"substance": "ESTRADIOL; NORETHINDRONE ACETATE",
"productndc": "70700-303",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA207261",
"marketing_category": "ANDA"
}See everything about estradiol; norethindrone acetate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.