warnings
WARNINGS Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted. Keep out of the reach of children.
ERGOCALCIFEROL
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
- Brand name
- ERGOCALCIFEROL
- Generic name
- ERGOCALCIFEROL
- Manufacturer
- Torrent Pharmaceuticals Limited
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 4ae38744-020d-4c37-a6f1-88f55c2f1047
- SPL ID
- b427fa56-1a5b-4826-9034-e82c697381d3
- Version
- 3
- Effective date
- 2026-09-04
- 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 06:28:41
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 003444 | derived:openfda.application_number |
| application number | NDA003444 | openfda.application_number | |
| brand name | ERGOCALCIFEROL | openfda.brand_name | |
| generic name | ERGOCALCIFEROL | openfda.generic_name | |
| manufacturer name | Torrent Pharmaceuticals Limited | openfda.manufacturer_name | |
| ndc | package | 13668-757-01 | openfda.package_ndc |
| ndc | product | 13668-757 | openfda.product_ndc |
| ndc11 | package | 13668075701 | derived:openfda.package_ndc |
| rxcui | 1367410 | openfda.rxcui | |
| spl id | b427fa56-1a5b-4826-9034-e82c697381d3 | id | |
| spl set id | 4ae38744-020d-4c37-a6f1-88f55c2f1047 | set_id | |
| unii | VS041H42XC | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Hypervitaminosis D is characterized by effects on the following organ system: Renal: Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS: Mental retardation. Soft Tissues: Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal: Bone demineralization (osteoporosis) in adults occurs concomitantly. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or 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.