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Bionara ULTRA Probiotic Dietary Supplement Capsules 14 410 mg; 410 mg; 410 mg; 410 mg; 25 mg; 10 mg Capsule, 30-count — NDC 85477-0710-30 package photo

Bionara ULTRA Probiotic Dietary Supplement Capsules 14 410 mg; 410 mg; 410 mg; 410 mg; 25 mg; 10 mg Capsule, 30-count

by Oncora Pharma, LLC · 30 CAPSULE in 1 BOTTLE (85477-710-30)
NDC 85477-0710-30
🏷️ FDA NDC (as labeled) 85477-710-30 billing pads the product segment with a zero
Rx only On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 85477-710-30
Product NDC 85477-710
11-digit billing NDC 85477071030
NCPDP billing unit EA — each (per item)
UNII D4S8K64J5Z, K1YRS2QLN2, QFC21096ON, GXW9U52VV9, HTV58LVI9P, N2UDM48ZD6
SPL Set ID bc5e4d0b-03ac-43a5-9155-8f3ceb9504cc
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-23
Route ORAL
Dosage form CAPSULE
Substance LACTOBACILLUS ACIDOPHILUS LA 14; BIFIDOBACTERIUM ANIMALIS LACTIS BL04; LACTIPLANTIBACILLUS PLANTARUM; LACTICASEIBACILLUS PARACASEI LPC-37; LESSONIA NIGRESCENS; BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES
GPI-14 47300025006500
GCN Seq No 088794
GCN 58965
HICL code 051232
Ingredient (HICL) L.acid,Parac,Plant/B.anim/Fos
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4D
Therapeutic class — specific (HIC3) Antidiarrheal Microorganisms Agents
AHFS code 56:92.00.00
AHFS class Gi Drugs, Miscellaneous
FDB label name BIONARA ULTRA 30 BILL CFU CAP
FDB brand name Bionara Ultra
Legend status Q — Non-drug — dietary supplement, vitamin, medical food, or herbal preparation
Why two NDCs? The FDA registers this code as 85477-710-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85477-0710-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerOncora Pharma, LLC
Labeler code85477
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio42 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BIONARA ULTRA 30 BILL CFU CAP Ingredient L.acid,Parac,Plant/B.anim/Fos
🧪 What is this product?

Bionara ULTRA is an oral capsule dietary supplement containing multiple probiotic bacterial strains (Bifidobacterium animalis lactis, Lacticaseibacillus paracasei, Lactiplantibacillus plantarum, and Lactobacillus acidophilus) along with fructooligosaccharides from sugar beet root and seaweed extract. The bacterial strains are commonly included in products intended to support digestive and intestinal health, while fructooligosaccharides function as a prebiotic fiber that may promote the growth of beneficial bacteria. This product is marketed without an approved FDA application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeCapsule
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII GMW67QNF9C
    Leucine is an amino acid derived from natural sources. It acts as a glidant and flow agent in powders and tablets, helping the medicine move smoothly during manufacturing and packaging.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bionara ULTRA 14 410 mg/1; 410 mg/1; 410 mg/1; 410 mg/1; 25 mg/1; 10 mgthis 85477-0710-30 Oncora 30 capsules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85477-0710-30 You're viewing this 30 CAPSULE in 1 BOTTLE (85477-710-30) 2026-02-23 Active

🧭 About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 85477-710-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85477-0710-30, written without dashes as 85477071030. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85477-0710-30, the first segment (85477) is the labeler code FDA assigned to Oncora Pharma, LLC; the middle segment (0710) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Oncora Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Oncora Pharma, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 27 words ▾

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 21 words ▾

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

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 46 words ▾

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.

📦 How Supplied / Storage and Handling 22 words ▾

HOW SUPPLIED Bionara Ultra™ is supplied as: 30 capsules per bottle NDC 85477-710-30 MANUFACTURER INFORMATION Manufactured for: Oncora Pharma Dallas, TX 75228

📦 Storage and Handling 25 words ▾

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.

📋 Description 63 words ▾

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)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85477-0623-30 · Oncora 85477-0711-30 · Oncora →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.