Bionara ULTRA

Product NDC
85477-710
11-digit product format
854770710
Labeler code
85477
Product ID
85477-710_6cd37233-b8b5-4018-b1e4-07611306a562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probiotic Dietary Supplement Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-02-23
Substance
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTICASEIBACILLUS PARACASEI LPC-37; LACTIPLANTIBACILLUS PLANTARUM; LACTOBACILLUS ACIDOPHILUS LA 14; LESSONIA NIGRESCENS
Active strength
10; 410; 410; 410; 410; 25 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bionara ULTRA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES10 mg/1
BIFIDOBACTERIUM ANIMALIS LACTIS BL04410 mg/1
LACTICASEIBACILLUS PARACASEI LPC-37410 mg/1
LACTIPLANTIBACILLUS PLANTARUM410 mg/1
LACTOBACILLUS ACIDOPHILUS LA 14410 mg/1
LESSONIA NIGRESCENS25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN2UDM48ZD6, K1YRS2QLN2, GXW9U52VV9, QFC21096ON, D4S8K64J5Z, HTV58LVI9P

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
85477-710-30Bionara ULTRA30 in 1 BOTTLECAPSULE301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-710-308547707103030 CAPSULE in 1 BOTTLE (85477-710-30) 30 capsule2026-02-23NoNoCurrent