FDA.reportPublic FDA data

Microvara

Manufacturer
Oncora Pharma, LLC
Effective date
2026-02-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:07:14

Label at a glance#

ProductMicrovara
Active ingredientLACTOBACILLUS ACIDOPHILUS, LACTIPLANTIBACILLUS PLANTARUM, LACTICASEIBACILLUS RHAMNOSUS, LIMOSILACTOBACILLUS FERMENTUM, LIMOSILACTOBACILLUS REUTERI, LESSONIA NIGRESCENS
Label structure9 sections

Indications and uses

Microvara™ is indicated as a probiotic dietary supplement to support digestive health and maintain normal intestinal flora. It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan.

Dosage and administration

Adults: Take two (2) capsules once daily, or as directed by a licensed healthcare practitioner.

Storage and handling

Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F). Protect from excessive heat, moisture, and light.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Microvara™ is a prescription-dispensed oral probiotic dietary supplement formulated to support gastrointestinal health and promote balance of normal intestinal microflora. Each serving (two capsules) provides 50 billion colony-forming units (CFU) of beneficial probiotic organisms combined with marine polysaccharide.

The proprietary probiotic blend includes:

  • Lactobacillus acidophilus
  • Lactobacillus plantarum
  • Lactobacillus rhamnosus
  • Lactobacillus fermentum
  • Lactobacillus reuteri

The formulation utilizes MAKTrek® Bi-Pass Technology to support probiotic viability during gastrointestinal transit.

Microvara™ is intended for use under the supervision of a licensed healthcare practitioner.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Microvara™ is indicated as a probiotic dietary supplement to support digestive health and maintain normal intestinal flora.

It is dispensed by prescription and intended for use under medical supervision as part of a dietary supplementation plan.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults: Take two (2) capsules once daily, or as directed by a licensed healthcare practitioner.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Microvara™ is contraindicated in individuals with known hypersensitivity to any of its ingredients.

WARNINGS AND PRECAUTIONS

WARNINGS SECTION

  • If pregnant, nursing, or attempting to conceive, consult a licensed healthcare professional prior to use.
  • Keep out of reach of children.
  • Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. In case of accidental overdose, call a physician or poison control center immediately.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Probiotic supplementation may occasionally result in mild gastrointestinal symptoms such as bloating, gas, or abdominal discomfort. If adverse reactions occur, discontinue use and consult a healthcare professional.

HOW SUPPLIED

HOW SUPPLIED SECTION

Microvara™ (NDC 85477-711-30) is supplied in bottles containing 30 capsules.

STORAGE

STORAGE AND HANDLING SECTION

Store at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F).
Protect from excessive heat, moisture, and light.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Microvara PDP
Microvara PDP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770711303GTIN-13: 0854770711303
EAN-13: 0854770711303
GTIN-12: 854770711303
UPC-A: 854770711303
GTIN storage (14 digits): 00854770711303		microvara-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-711-30Microvara30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-711-30EA - Each85477-711db516ad4-0338-4d34-b03d-388742a121e912026-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-71185477-711-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOBACILLUS ACIDOPHILUS1PRR1V42V5ACTIB
LACTIPLANTIBACILLUS PLANTARUMQFC21096ONACTIB
LACTICASEIBACILLUS RHAMNOSUS9601IVB87JACTIB
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APACTIB
LIMOSILACTOBACILLUS REUTERI9913I24QEEACTIB
LESSONIA NIGRESCENSHTV58LVI9PACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
LEUCINEGMW67QNF9CIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MicrovaraPROBIOTIC DIETARY SUPPLEMENTOncora Pharma, LLC70b1e715-2b36-4b9b-af84-8e90dfe97ad12026-02-23Warnings, Adverse reactionsExact identifier
ndc (package): 85477-711-30
ndc (product): 85477-711
ndc11 (package): 85477071130
spl id: f744cd1a-0b65-48b0-b2b6-d3fbaa7a4e86
spl set id: 70b1e715-2b36-4b9b-af84-8e90dfe97ad1

Reported adverse events (FAERS/openFDA)#

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