VITAMIN D 1.25 mg/1
ergocalciferol · CAPSULE · Strides Pharma Science Limited
VITAMIN D is a capsule containing ergocalciferol at 1.25 mg/1, taken oral. Manufactured by Strides Pharma Science Limited.
Key Facts
- Brand Name
- VITAMIN D
- Generic Name
- ergocalciferol
- NDC Code (Product)
64380-737- Manufacturer
- Strides Pharma Science Limited
- Strength
- 1.25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090455
- Drug Class
- Provitamin D2 Compound [EPC]
- Marketing Start
- 05/16/2014
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Alva-Amco Pharmacal Companies., Inc.
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Safecor Health, LLC
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Partell Specialty Pharmacy
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Dosage & Administration
Directions Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months: ask a doctor. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours do not spray directly on face. Spray into hands and apply to face. Use in well-ventilated areas. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum of SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses
Warnings
Warnings For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use
Frequently Asked Questions
What is VITAMIN D used for?
VITAMIN D contains ergocalciferol. It is a capsule taken oral. Consult your doctor for specific uses.
Is VITAMIN D a controlled substance?
VITAMIN D is not classified as a controlled substance by the DEA.
What is the generic name for VITAMIN D?
The generic name for VITAMIN D is ergocalciferol. There are 6 other brand versions of ergocalciferol.
What is the NDC code for VITAMIN D 1.25 mg/1?
The NDC (National Drug Code) for VITAMIN D 1.25 mg/1 is 64380-737, listed by Strides Pharma Science Limited.