PYRIDOXINE HCI

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: PYRIDOXINE HCI
Generic name: PYRIDOXINE HCI
Manufacturer: HF Acquisition Co LLC, DBA HealthFirst
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 946c8e50-08d0-755d-e053-2a95a90a84de
SPL ID: 0ffba8c5-bf5d-a665-e063-6294a90a64f6
Version: 4
Effective date: 2024-01-28
Source export date: 2026-09-28
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/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:24:00

Harmonized routes table
Harmonized routes
INTRAMUSCULAR, INTRAVENOUS

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
application applno	ANDA	080618	derived:openfda.application_number
application number		ANDA080618	openfda.application_number
brand name		PYRIDOXINE HCI	openfda.brand_name
generic name		PYRIDOXINE HCI	openfda.generic_name
manufacturer name		HF Acquisition Co LLC, DBA HealthFirst	openfda.manufacturer_name
ndc	package	51662-1410-3	openfda.package_ndc
ndc	package	51662-1410-1	openfda.package_ndc
ndc	package	51662-1410-2	openfda.package_ndc
ndc	product	51662-1410	openfda.product_ndc
ndc11	package	51662141002	derived:openfda.package_ndc
ndc11	package	51662141003	derived:openfda.package_ndc
ndc11	package	51662141001	derived:openfda.package_ndc
rxcui		312736	openfda.rxcui
spl id		0ffba8c5-bf5d-a665-e063-6294a90a64f6	id
spl set id		946c8e50-08d0-755d-e053-2a95a90a84de	set_id
unii		68Y4CF58BV	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Paresthesia, somnolence, and low serum folic acid levels have been reported.

Reported adverse events (FAERS/openFDA)#

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