United States· US:64380-441_eb9cfb36-9266-4334-b613-38153715a9bd
hydrocodone bitartrate and acetaminophen
A medicinal product containing hydrocodone bitartrate; acetaminophen, registered in United States by Strides Pharma Science Limited.
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
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Manufacturer
- Strides Pharma Science Limited
- 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
- ndc116438044101100 TABLET in 1 BOTTLE (64380-441-01)
- ndc1164380-441-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/c9229423-4035-42a3-94c3-4a7f94307c3a GET /v1/drugs/c9229423-4035-42a3-94c3-4a7f94307c3a?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": "7.5; 325",
"substance": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"productndc": "64380-441",
"dosage_form": "TABLET",
"dea_schedule": "CII",
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA202935",
"marketing_category": "ANDA"
}See everything about hydrocodone bitartrate; acetaminophen.
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.