United States· US:46287-014_8691f6bc-18e9-4336-8e10-c702ecace00a

Oracit

A medicinal product containing citric acid monohydrate; trisodium citrate dihydrate, registered in United States by CMP Pharma, 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…normalisedOracitATC—REGISTER NO.US:46287-014_8691f6bc…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
Manufacturer
CMP Pharma, 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 · 6

  • ndc11
    46287-014-01
  • ndc11
    46287-014-15
  • ndc11
    46287-014-30
  • ndc11
    4628701401
    500 mL in 1 BOTTLE (46287-014-01)
  • ndc11
    4628701415
    10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSE
  • ndc11
    4628701430
    10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSE

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/b64d565a-3c19-465b-835f-16559c70931b
GET /v1/drugs/b64d565a-3c19-465b-835f-16559c70931b?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": "640; 490",
  "substance": "CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE",
  "productndc": "46287-014",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER"
}

See everything about citric acid monohydrate; trisodium citrate dihydrate.

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.