BIONARA ULTRA- probiotic dietary supplement capsules capsule

Bionara ULTRA by

Drug Labeling and Warnings

Bionara ULTRA by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PRODUCT DESCRIPTION

Bionara Ultra™ is a prescription probiotic dietary supplement containing a proprietary blend of probiotic bacteria providing 60 billion CFU per serving (2 capsules), combined with prebiotic and polysaccharide support ingredients.

Each serving (2 capsules) contains 820 mg of proprietary probiotic blend delivering 60 billion CFU, including:

• MATREK® (Bi-Pass Technology)
  
• Lactobacillus acidophilus (La-14)
  
• Bifidobacterium lactis (Bl-04)
  
• Lactobacillus plantarum (Lp-115)
  
• Lactobacillus paracasei (Lpc-37)

INDICATIONS AND USAGE

Bionara Ultra™ is a prescription probiotic supplement intended to support gastrointestinal health and maintain normal intestinal flora balance.

Dispensed by prescription under medical supervision.

DOSAGE AND ADMINISTRATION

Usual adult dose is 2 capsules once or twice daily or as prescribed by a licensed medical practitioner.

WARNINGS

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

If pregnant, lactating, or trying to conceive, consult with a licensed healthcare professional prior to use.

CONTRAINDICATIONS

None known.

STORAGE

Store at 20°–25°C (68°–77°F).
Excursions permitted to 15°–30°C (59°–86°F) [See USP Controlled Room Temperature].

Avoid excessive heat, light, moisture, and exceeding 85% humidity.

HOW SUPPLIED

Bionara Ultra™ is supplied as:

• 30 capsules per bottle
  
• NDC: 85477-710-30

MANUFACTURER INFORMATION

Manufactured for:
Oncora Pharma
Dallas, TX 75228

Principal Display Panel

85477-710-30
Bionara
ULTRA
60 billion CFU
30 Capsules

INGREDIENTS AND APPEARANCE

BIONARA ULTRA 
probiotic dietary supplement capsules capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-710
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTOBACILLUS ACIDOPHILUS LA 14 (UNII: D4S8K64J5Z) (LACTOBACILLUS ACIDOPHILUS LA 14 - UNII:D4S8K64J5Z)	LACTOBACILLUS ACIDOPHILUS LA 14	410 mg
BIFIDOBACTERIUM ANIMALIS LACTIS BL04 (UNII: K1YRS2QLN2) (BIFIDOBACTERIUM ANIMALIS LACTIS BL04 - UNII:K1YRS2QLN2)	BIFIDOBACTERIUM ANIMALIS LACTIS BL04	410 mg
LACTIPLANTIBACILLUS PLANTARUM (UNII: QFC21096ON) (LACTIPLANTIBACILLUS PLANTARUM - UNII:QFC21096ON)	LACTIPLANTIBACILLUS PLANTARUM	410 mg
LACTICASEIBACILLUS PARACASEI LPC-37 (UNII: GXW9U52VV9) (LACTICASEIBACILLUS PARACASEI LPC-37 - UNII:GXW9U52VV9)	LACTICASEIBACILLUS PARACASEI LPC-37	410 mg
LESSONIA NIGRESCENS (UNII: HTV58LVI9P) (LESSONIA NIGRESCENS - UNII:HTV58LVI9P)	LESSONIA NIGRESCENS	25 mg
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6) (BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES - UNII:N2UDM48ZD6)	BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES	10 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LEUCINE (UNII: GMW67QNF9C)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-710-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/23/2026

Labeler - Oncora Pharma, LLC (119482542)