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Ergocalciferol 1.25 mg Capsule, Liquid Filled, 8-count — NDC 43353-0238-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ergocalciferol 1.25 mg Capsule, Liquid Filled, 8-count — NDC 43353-238-08 (Billing 43353-0238-08)

by Aphena Pharma Solutions - Tennessee, LLC · 8 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 8 capsules of Ergocalciferol 1.25 mg Capsule, Liquid Filled from Aphena Pharma Solutions - Tennessee, LLC, marketed since Jul 2015 and currently FDA-listed.

NDC 43353-0238-08
🏷️ FDA NDC (as labeled) 43353-238-08 billing pads the product segment with a zero
This package
Contains8-count Pack sizes5 compare ↓
Product page 43353-0238-03 Also comes in: 3 capsules 43353-238-03 4 capsules 43353-238-04 12 capsules 43353-238-12 13 capsules 43353-238-13
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43353-238-08
Product NDC 43353-238
11-digit billing NDC 43353023808
NCPDP billing unit EA — each (per item)
RxCUI 1367410
UNII VS041H42XC
Application # ANDA080704
SPL Set ID 2841b0ba-3b09-4f03-a060-9fb7f1af8344
Established class (EPC) Provitamin D2 Compound
Chemical class Ergocalciferols
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-23
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ERGOCALCIFEROL
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 77202030000110
GPI class Vitamin D (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 VITAMIN D2 1.25MG(50,000 UNIT)
FDB brand name Vitamin D2
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002169
  • GCN: 94422
  • GPI-14 (Medi-Span): 77202030000110
  • HICL (First Databank): 000995
  • AHFS class code: 88:16.00.00
  • RxCUI (RxNorm): 1367410
Why two NDCs? The FDA registers this code as 43353-238-08 — 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 → 43353-0238-08. 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.

RxNorm drug class

This medicine belongs to the Provitamin D2 Compound class.

Pharmacologic class Provitamin D2 Compound
Drug family (ATC) Vitamin D and analogues
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VITAMIN D2 1.25MG(50,000 UNIT) 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 is vitamin D2, and it is prescribed for hypoparathyroidism, vitamin D resistant rickets, and familial hypophosphatemia. Your doctor will explain which one applies to you.
  • Take it by mouth as a capsule, exactly as your prescriber directs. Your dose is individualized, so don't change it on your own. Make sure you get enough calcium, and keep your bloo...
  • The safe range for vitamin D is narrow, and too much can raise your calcium too high. Blood calcium and phosphorus are checked every 2 weeks or more often. Bone X-rays are done mon...
  • Nausea, poor appetite, constipation, weight loss, and vague aches or weakness can signal too much vitamin D. Heavy thirst and frequent urination are also warning signs. Call me or...
📖 Read our full Ergocalciferol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 3 capsules 4 capsules 12 capsules 13 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43353-0238-03 43353-238-03 Main listing 3 CAPSULE, LIQUID FILLED in 1 BOTTLE 2016-12-09 — Active
43353-0238-04 43353-238-04 4 CAPSULE, LIQUID FILLED in 1 BOTTLE 2018-09-16 — Active
43353-0238-08 You're viewing this 8 CAPSULE, LIQUID FILLED in 1 BOTTLE 2018-09-16 — Active
43353-0238-12 43353-238-12 12 CAPSULE, LIQUID FILLED in 1 BOTTLE 2018-09-16 — Active
43353-0238-13 43353-238-13 13 CAPSULE, LIQUID FILLED in 1 BOTTLE 2018-12-13 — Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 8-count package — 8 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 43353-0238-03?
Both are Ergocalciferol 1.25 mg Capsule, Liquid Filled — the drug itself is identical. This page's package is the 8-count one, while NDC 43353-0238-03 is the 3 capsules package.
What NDC number is used to bill for this package of Ergocalciferol 1.25 mg Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ergocalciferol 1.25 mg 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 mgthis 43353-0238-08 Aphena 8 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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color green
ShapeOval
ImprintPA140
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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 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.

6 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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderBIONPHARMA INC
FDA applicationANDA080704 (ANDA)
Labeler code43353
First marketedJul 2015
Product typeHuman Prescription Drug
Portfolio800 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.

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 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 & ADMINISTRATION THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. Vitamin D Resistant Rickets 12,000 to 500,000 USP units daily. Hypoparathyroidism 50,000 to 200,000 USP 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 phosphorous 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 114 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. AvKARE, Inc. at 1-855-361-3993; email [email protected] ; 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 109 words ▾

PREGNANCY CATEGORY C 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 USP units of vitamin D daily during pregnancy has not been established.

🧒 Pediatric Use 12 words ▾

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

🧓 Geriatric Use 107 words ▾

GERIATRIC USE Clinical studies of Ergocalciferol capsules, USP 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: Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis. 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.

Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. 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).

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 cardio vascular 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 147 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 phosphorous 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 69 words ▾

HOW SUPPLIED Each green, oval softgel is imprinted with PA140 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP, and is available in bottles of 100 (42291-266-01) Softgels. Store at 25° C (77° F); excursionns permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

📦 Storage and Handling 38 words ▾

Store at 25° C (77° F); excursionns permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

📋 Description 168 words ▾

DESCRIPTION ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble inorganic 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 softgel, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2 , is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C 28 H 44 O) with a molecular weight of 396.65, and has the following structural formula: Inactive Ingredients : Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1. structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS GENERAL Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects.

IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations. In the treatment of hypoparathyroidism, intravenous calcium, parathyroid hormone, and/or dihydrotachysterol may be required.

Maintenance of a normal serum phosphorous level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatis calcification. Adequate dietary calcium is necessary for clinical response to vitamin D therapy. Protect from light.

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. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No long-term animal studies have been performed to evaluate the drug's potential in these areas.

PREGNANCY CATEGORY C 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 USP units of vitamin D daily during pregnancy has not been established. NURSING MOTHERS Caution should be exercised when ergocalciferol is administered to a nursing woman.

In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infant's serum calcium concentration is required in that case (Goldberg, 1972). PEDIATRIC USE Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION ).

GERIATRIC USE Clinical studies of Ergocalciferol capsules, USP 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.

🍼 Nursing Mothers 48 words ▾

NURSING MOTHERS Caution should be exercised when ergocalciferol is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infant's serum calcium concentration is required in that case (Goldberg, 1972).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No long-term animal studies have been performed to evaluate the drug's potential in these areas.

📄 Package Label / Principal Display Panel 24 words ▾

PRINCIPAL DISPLAY PANEL - 1.25 mg NDC 43353-238 - Ergocalciferol (50,000 USP Units Vitamin D) 1.25 mg - Rx Only Bottle Label 1.25 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 3 capsules (43353-0238-03), 4 capsules (43353-0238-04), 12 capsules (43353-0238-12). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 43353-0218-53 · Aphena 43353-0240-45 · Aphena →
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.