HomeNDC LookupIngredientsErgocalciferol › 13668-0757-01
ERGOCALCIFEROL 1.25 mg Capsule, 100-count — NDC 13668-0757-01 package photo

ERGOCALCIFEROL 1.25 mg Capsule, 100-count

by Torrent Pharmaceuticals Limited · 100 CAPSULE in 1 BOTTLE (13668-757-01)
NDC 13668-0757-01
🏷️ FDA NDC (as labeled) 13668-757-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 13668-757-01
Product NDC 13668-757
11-digit billing NDC 13668075701
NCPDP billing unit EA — each (per item)
UNII VS041H42XC
UPC 0313668757019
Application # NDA003444
SPL Set ID 4ae38744-020d-4c37-a6f1-88f55c2f1047
Established class (EPC) Provitamin D2 Compound
Chemical class Ergocalciferols
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-10
Route ORAL
Dosage form CAPSULE
Substance ERGOCALCIFEROL
GCN Seq No 002169
GCN 94422
HICL code 000995
Ingredient (HICL) Ergocalciferol (Vitamin D2)
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6D
Therapeutic class — specific (HIC3) Vitamin D Preparations
AHFS code 88:16.00.00
AHFS class Vitamin D
FDB label name ERGOCALCIFEROL 1.25 MG CAPSULE
FDB brand name Ergocalciferol (Vitamin D2)
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 13668-757-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 13668-0757-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerTorrent Pharmaceuticals Limited
Application holderESJAY PHARMA LLC
FDA applicationNDA003444 (NDA)
Labeler code13668
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio182 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ERGOCALCIFEROL 1.25 MG CAPSULE Ingredient Ergocalciferol (Vitamin D2)
📖 What it is MedlinePlus · NLM

Ergocalciferol is used in the treatment of hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone), refractory rickets (softening and weakening of bones that does not respond to treatment), and familial hypophosphatemia (rickets or osteomalacia caused by an inherited condition with a decreased ability to break down vitamin D in the body). Ergocalciferol is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's the same type of vitamin D (vitamin D2), but at much higher doses. The over-the-counter supplements you see on store shelves are for general wellness, while this prescription...
  • Is this the same vitamin D I can buy at the pharmacy without a prescription?
  • Because the line between a helpful dose and a harmful one is very narrow with ergocalciferol. Too much vitamin D raises your calcium levels to dangerous heights, which can damage y...
  • Why does my doctor keep ordering blood tests while I'm on this medication?
📖 Read our full Ergocalciferol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Green
ShapeOval
ImprintE09
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.114 $11.36 / 100 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jun 2026 Jul 2026 Aug 2026 $0.116 $0.114
▼ Down 2% over the last 3 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ergocalciferol 1.25 mgthis 13668-0757-01 Torrent 100 capsules $0.114 AA Availability likely
Ergocalciferol Capsules, 1.25 mg 42806-0547-01 Epic 100 capsules $0.114 AA Availability likely
Vitamin D 1.25 mg 50268-0297-15 AvPAK 50 capsules $0.114 AA Availability likely
Ergocalciferol 1.25 mg 62135-0439-90 Chartwell 90 capsules $0.114 AA Availability likely
Vitamin D 1.25 mg 64380-0737-06 Strides 100 capsules $0.114 AA Availability likely
Ergocalciferol 1.25 mg 69452-0151-20 Bionpharma 100 capsules $0.114 AA Availability likely
Ergocalciferol 1.25 mg 42291-0266-01 AvKARE 100 capsules AA FDA listed
Ergocalciferol 1.25 mg 43063-0711-12 PD-Rx 12 capsules AA FDA listed
Ergocalciferol 1.25 mg 43353-0238-03 Aphena 3 capsules AA FDA listed
Ergocalciferol 1.25 mg 50090-5844-01 A-S 8 capsules AA FDA listed
Vitamin D 1.25 mg 51407-0700-01 Golden 100 capsules AA FDA listed
Ergocalciferol Capsules, 1.25 mg 51655-0730-80 Northwind 8 capsules AA FDA listed
Vitamin D 1.25 mg 51655-0774-27 Northwind 12 capsules AA FDA listed
Ergocalciferol 1.25 mg 60760-0152-12 St. 12 capsules AA FDA listed
Vitamin D 1.25 mg 61919-0702-04 DirectRX 4 capsules AA FDA listed
Vitamin D 1.25 mg 63187-0519-06 Proficient 6 capsules AA FDA listed
Ergocalciferol 1.25 mg 63629-2447-01 Bryant 100 capsules AA FDA listed
Ergocalciferol 1.25 mg 63629-7913-01 Bryant 90 capsules AA FDA listed
Ergocalciferol 1.25 mg 68071-1951-02 NuCare 12 capsules AA FDA listed
Ergocalciferol 1.25 mg 68071-2295-01 NuCare 100 capsules AA FDA listed
Ergocalciferol Capsules, 1.25 mg 68788-4042-01 Preferred 100 capsules AA FDA listed
Ergocalciferol 1.25 mg 68788-4092-01 Preferred 100 capsules AA FDA listed
Vitamin D 1.25 mg 68788-7627-01 Preferred 100 capsules AA FDA listed
Ergocalciferol 1.25 mg 70518-0177-03 REMEDYREPACK 1 capsule AA Discontinued
Vitamin D 1.25 mg 70518-1878-01 REMEDYREPACK 12 capsules AA FDA listed
Ergocalciferol Capsules, 1.25 mg 70518-3472-00 REMEDYREPACK 4 capsules AA Discontinued
Ergocalciferol Capsules, 1.25 mg 71205-0676-30 Proficient 30 capsules AA FDA listed
Ergocalciferol 1.25 mg 71335-0062-00 Bryant 45 capsules AA FDA listed
Vitamin D 1.25 mg 71335-0278-00 Bryant 45 capsules AA FDA listed
Ergocalciferol 1.25 mg 71335-1691-00 Bryant 45 capsules AA FDA listed
Ergocalciferol 1.25 mg 71335-1699-01 Bryant 90 capsules AA FDA listed
Ergocalciferol Capsules, 1.25 mg 71335-2003-01 Bryant 4 capsules AA FDA listed
Ergocalciferol 1.25 mg 71335-2246-01 Bryant 4 capsules AA FDA listed
Vitamin D 1.25 mg 71610-0552-04 Aphena 4 capsules AA FDA listed
Ergocalciferol 1.25 mg 71610-0712-03 Aphena 3 capsules AA FDA listed
Vitamin D 1.25 mg 72789-0249-01 PD-Rx 100 capsules AA FDA listed
Ergocalciferol (Vitamin D2) 1.25 mg 80425-0130-03 Advanced 12 capsules AA FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ERGOCALCIFEROL — the ingredient across all brands.

Top reported reactions

Fatigue37,945
Nausea28,189
Diarrhoea27,097
Headache25,982
Pain24,231
Dyspnoea20,506
Arthralgia20,181

Age at onset

Neonate241
Infant164
Child696
Adolescent974
Adult32,535
Elderly32,898

Reporter sex

382,600 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization102,610
Death22,817
Disabling15,123
Life-threatening11,609
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 28,692 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
13668-0757-01 You're viewing this 100 CAPSULE in 1 BOTTLE (13668-757-01) 2026-02-10 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 25 words

INDICATIONS AND USAGE Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

⏱️ Dosage and Administration 83 words

DOSAGE AND ADMINISTRATION THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets: 12,000 to 500,000 IU units daily. Hypoparathyroidism: 50,000 to 200,000 IU units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION. Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary.

X-rays of the bones should be taken every month until condition is corrected and stabilized.

Contraindications 22 words

CONTRAINDICATIONS Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

⚠️ Warnings 31 words

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.

🤒 Adverse Reactions 117 words

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.

🔄 Drug Interactions 32 words

Drug Interactions Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations. Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.

🤰 Pregnancy 106 words

Pregnancy Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation.

For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 IU of vitamin D daily during pregnancy has not been established.

🧒 Pediatric Use 11 words

Pediatric Use Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).

🧓 Geriatric Use 105 words

Geriatric Use Clinical studies of ergocalciferol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger individuals.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~1 min read

OVERDOSAGE The effects of administered vitamin D can persist for two or more months after cessation of treatment. Hypervitaminosis D is characterized by: 1. Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis.

2. 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. 3.

Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Bone demineralization (osteoporosis) in adults occurs concomitantly. 4.

Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism). The treatment of hypervitaminosis D with hypercalcemia consists in immediate withdrawal of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment.

The first step should be hydration of the patient. Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion.

Other reported therapeutic measures include dialysis or the administration of citrates, sulfates, phosphates, corticosteroids, EDTA (ethylenediaminetetraacetic acid), and mithramycin via appropriate regimens. With appropriate therapy, recovery is the usual outcome when no permanent damage has occurred. Deaths via renal or cardiovascular failure have been reported.

The LD 50 in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.

🧬 Clinical Pharmacology 148 words

CLINICAL PHARMACOLOGY The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1, 25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization.

Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules. There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

📦 How Supplied / Storage and Handling 90 words

HOW SUPPLIED Capsules of 1.25 mg (50,000 IU vitamin D) of ergocalciferol, USP are clear, forest green, oval, soft gelatin capsules laser printed with “E09” supplied in HDPE bottles: Bottles of 100 - NDC 13668-757-01 Store at 77°F (25°C); excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. Rx Only Manufactured by: Esjay Pharma Private Limited, Tamilnadu, India - 602117 Distributed by: Torrent Pharma INC.

Basking Ridge, NJ 07920. 8113605 P3495/01/25 Rev. 09/2026 logo

📋 Description 169 words

DESCRIPTION Ergocalciferol capsules, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light.

Ergosterol or provitamin D 2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 IU.

Each capsule contains 1.25 mg (50,000 International Units vitamin D) of ergocalciferol, USP, in an edible vegetable oil. Ergocalciferol, also called vitamin D 2 , is 9, 10-secoergosta-5,7,10 (19), 22-tetraen-3-ol, (3ß,5Z,7E,22 E )-; (C 28 H 44 O) with a molecular weight of 396.65, and has the following structural formula: Inactive Ingredients: Butylated Hydroxylanisole, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Purified Water, Soybean Oil. ergocalciferol1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.