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United States· US:63187-375_6124893c-8e7a-4f34-a81c-8fd9fb1c3ba8

Hydrocodone Bitartrate and Acetaminophen

A medicinal product containing hydrocodone bitartrate; acetaminophen, registered in United States by Proficient Rx LP.

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:63187-375_6124893c…PACKS LISTED10CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Manufacturer
Proficient Rx LP
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 · 10

  • ndc11
    6318737512
    12 TABLET in 1 BOTTLE (63187-375-12)
  • ndc11
    6318737515
    15 TABLET in 1 BOTTLE (63187-375-15)
  • ndc11
    6318737520
    20 TABLET in 1 BOTTLE (63187-375-20)
  • ndc11
    6318737530
    30 TABLET in 1 BOTTLE (63187-375-30)
  • ndc11
    6318737560
    60 TABLET in 1 BOTTLE (63187-375-60)
  • ndc11
    63187-375-12
  • ndc11
    63187-375-15
  • ndc11
    63187-375-20
  • ndc11
    63187-375-30
  • ndc11
    63187-375-60

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/d2164cf2-ea57-4206-acd3-964d51b2568d
GET /v1/drugs/d2164cf2-ea57-4206-acd3-964d51b2568d?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; 325",
  "substance": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
  "productndc": "63187-375",
  "dosage_form": "TABLET",
  "dea_schedule": "CII",
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA201013",
  "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.