Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Bionara ULTRA Probiotic Dietary Supplement Capsules 14 410 mg; 410 mg; 410 mg; 410 mg; 25 mg; 10 mg Capsule, 30-count — NDC 85477-710-30 (Billing 85477-0710-30)
by Oncora Pharma, LLC · 30 CAPSULE in 1 BOTTLE
This is a package of 30 capsules of Bionara ULTRA Probiotic Dietary Supplement Capsules 14 410 mg; 410 mg; 410 mg; 410 mg; 25 mg; 10 mg Capsule from Oncora Pharma, LLC, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.
NDC 85477-0710-30
🏷️ FDA NDC (as labeled)
85477-710-30
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 85477-710-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 85477 labeler · 710 product · 30 package
- Package marketed since
- Feb 23, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 8547771030 1
- FDA record last changed
- Aug 27, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
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
Quick answers
- GSN (GCN sequence number): 088794
- GCN: 58965
- GPI-14 (Medi-Span): 47300025006500
- HICL (First Databank): 051232
- AHFS class code: 56:92.00.00
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Probiotic Dietary Supplement Capsules?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 85477-0710-30 You're viewing this Main listing | 30 CAPSULE in 1 BOTTLE | 2026-02-23 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
- FDA label on DailyMed · label index refreshed Oct 8, 2026
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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.
Manufacturer & labeler
LabelerOncora Pharma, LLC
Labeler code85477
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio42 products on file
More NDCs from Oncora Pharma, LLC labeler code 85477
- Folartex Multivitamin 300 ug; 60 mg; 10 ug; 4.5 mg; 26 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet NDC 85477-511-30
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- Folyra Multivitamin 300 ug; 60 mg; 10 ug; 4.5 mg; 26 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet NDC 85477-523-30
- Virexa Vitamin C, Vitamin D3, Vitamin B1, Vitamin B6, Vitamin B12, Folic Acid, NADH, Ubiquinone 125 mg; 12.5 ug; 25 mg; 125 mg; 1.667 mg; 1 mg; 5 mg; 50 mg Tablet NDC 85477-606-30
- Lumavex Multivitamin 5 mg; 35.7 mg; 25 mg; 65 mg; 20 mg; 5 mg; 1.67 mg; .5 mg Capsule NDC 85477-610-30
- Lunavira Multivitamin 5 mg; 35.7 mg; 25 mg; 65 mg; 20 mg; 5 mg; 1 mg; .5 mg Capsule NDC 85477-623-30
- Microvara Probiotic Dietary Supplement 217 mg; 217 mg; 217 mg; 217 mg; 217 mg; 20 mg Capsule NDC 85477-711-30
- Probentra Probiotic Dietary Supplement Capsules 14 400 mg; 400 mg; 400 mg; 400 mg; 30 mg; 12 mg Capsule NDC 85477-712-30
- LidexaGel 5% Lidocaine HCl 50 mg/g Gel NDC 85477-730-07
- Folvyris Folate, Vitamin D3 1.7 mg; .125 mg Tablet NDC 85477-823-30
- Folaten Multivitamin 300 ug; 60 mg; 10 ug; 4.5 mg; 26 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet NDC 85477-901-30
- Folixia Multivitamin 20 mg; .15 mg; 26 mg; .3 mg; 60 mg; .1 mg; .28 mg; 1.67 mg; .013 mg; 80 mg Tablet NDC 85477-902-30
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
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 ▾
DOSAGE AND ADMINISTRATION Usual adult dose is 2 capsules once or twice daily or as prescribed by a licensed medical practitioner.
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
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 ▾
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 ▾
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 ▾
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)
📄 Package Label / Principal Display Panel ▾
Principal Display Panel 85477-710-30 Bionara ULTRA 60 billion CFU 30 Capsules 85477-710-30 Bionara ULTRA 60 billion CFU 30 Capsules
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
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.