Probentra

Product NDC
85477-712
11-digit product format
854770712
Labeler code
85477
Product ID
85477-712_e357f4a7-006b-4dcf-8f8c-8157f5f817ef
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
12; 400; 400; 400; 400; 30 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
Probentra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACTOBACILLUS ACIDOPHILUS LA 1412 mg/1
BIFIDOBACTERIUM ANIMALIS LACTIS BL04400 mg/1
LACTIPLANTIBACILLUS PLANTARUM400 mg/1
LACTICASEIBACILLUS PARACASEI LPC-37400 mg/1
LESSONIA NIGRESCENS400 mg/1
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D4S8K64J5ZInternal UNII lookup
K1YRS2QLN2Internal UNII lookup
QFC21096ONInternal UNII lookup
GXW9U52VV9Internal UNII lookup
HTV58LVI9PInternal UNII lookup
N2UDM48ZD6Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c0e1b3e-f1a3-451d-a5c6-45bdf13274f8Available on FDA.report

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
85477-712-30Probentra30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-712-30EA - Each85477-712c452b3b6-d90e-42de-8320-a32eac5ce6c812026-04-20

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
ProbentraPROBIOTIC DIETARY SUPPLEMENT CAPSULESOncora Pharma, LLC7c0e1b3e-f1a3-451d-a5c6-45bdf13274f82026-02-25Warnings, Adverse reactionsExact identifier
ndc (product): 85477-712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-712-308547707123030 CAPSULE in 1 BOTTLE (85477-712-30) 30 capsule2026-02-23NoNoCurrent