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United States· US:43386-352_cc982f78-de8c-4384-9f43-ffad4169abdd

Hydrocodone Bitartrate and Acetaminophen

A medicinal product containing hydrocodone bitartrate; acetaminophen, registered in United States by Lupin Pharmaceuticals,Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedHydrocodone Bitartrate and Acetaminop…ATC—REGISTER NO.US:43386-352_cc982f78…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Manufacturer
Lupin Pharmaceuticals,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 · 4

  • ndc11
    4338635201
    100 TABLET in 1 BOTTLE (43386-352-01)
  • ndc11
    4338635205
    500 TABLET in 1 BOTTLE (43386-352-05)
  • ndc11
    43386-352-01
  • ndc11
    43386-352-05

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/ab44bff3-6ad3-4088-a0e1-c52ea536a5df
GET /v1/drugs/ab44bff3-6ad3-4088-a0e1-c52ea536a5df?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; 300",
  "substance": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
  "productndc": "43386-352",
  "dosage_form": "TABLET",
  "dea_schedule": "CII",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA206142",
  "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.