Oracit

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Oracit
Generic name: CITRIC ACID AND SODIUM CITRATE
Manufacturer: CMP Pharma, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: bc26abed-8e6e-475d-8ab3-abf7d0377003
SPL ID: 8691f6bc-18e9-4336-8e10-c702ecace00a
Version: 5
Effective date: 2023-12-07
Source export date: 2026-11-06
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/8ec9b1418c25a8bb472a36e6bc0b2cbabb210d48d5dd734197e022d21529ed58/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 09:14:22

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Oracit	openfda.brand_name
generic name		CITRIC ACID AND SODIUM CITRATE	openfda.generic_name
manufacturer name		CMP Pharma, Inc.	openfda.manufacturer_name
ndc	package	46287-014-15	openfda.package_ndc
ndc	package	46287-014-01	openfda.package_ndc
ndc	package	46287-014-30	openfda.package_ndc
ndc	product	46287-014	openfda.product_ndc
ndc11	package	46287001415	derived:openfda.package_ndc
ndc11	package	46287001430	derived:openfda.package_ndc
ndc11	package	46287001401	derived:openfda.package_ndc
rxcui		544550	openfda.rxcui
rxcui		544553	openfda.rxcui
spl id		8691f6bc-18e9-4336-8e10-c702ecace00a	id
spl set id		bc26abed-8e6e-475d-8ab3-abf7d0377003	set_id
unii		2968PHW8QP	openfda.unii
unii		B22547B95K	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions. To report suspected adverse reactions, contact CMP Pharma, Inc., toll free at 1-844-321-1443 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.