United States· US:69097-388_a425ceed-bb59-48bb-be43-cf47dbe21fef
DAPAGLIFLOZIN
A medicinal product containing dapagliflozin propanediol, registered in United States by Cipla USA Inc..
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
- DAPAGLIFLOZIN PROPANEDIOL
- Manufacturer
- Cipla USA Inc.
- 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 · 1
- ndc1169097-388-02
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dapagliflozin propanediol in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaDAGETIAMedochemie Ltd., Limassol
- FinlandDapagliflozin KrkaKRKA d.d. Novo mesto
- BelgiumDapagliflozin EG 5 mgEG
- IrelandDapagliflozin Clonmel 5 mg film-coated tabletsClonmel Healthcare Ltd
- GermanyDapagliflozin CiplaCipla Europe Nv
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Austria · Dapagliflozin Denk
- Germany · Dapagliflozin Cipla
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/1b5d4bf8-c927-45f7-85e0-e950727d46cb GET /v1/drugs/1b5d4bf8-c927-45f7-85e0-e950727d46cb?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",
"substance": "DAPAGLIFLOZIN PROPANEDIOL",
"productndc": "69097-388",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA211535",
"marketing_category": "ANDA"
}See everything about dapagliflozin propanediol.
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.