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Spirudio 12 [hp_C]/U Tablet, 60 us — NDC 87754-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Spirudio 12 [hp_C]/U Tablet, 60 us — NDC 87754-0001-1 (Billing 87754-0001-01)

by PROGRESYVUS TYRIMAI MB · 60 U in 1 BOTTLE

This is a package of 60 us of Spirudio 12 [hp_C]/U Tablet from PROGRESYVUS TYRIMAI MB, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 87754-0001-01
🏷️ FDA NDC (as labeled) 87754-0001-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 87754-0001-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87754 labeler · 0001 product · 1 package
Package marketed since
Jun 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0860013281212
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87754-0001-1
Product NDC 87754-0001
11-digit billing NDC 87754000101
UNII A4FH976KAQ
UPC 0860013281212
SPL Set ID 537294e5-3646-7e41-e063-6294a90a145a
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-01
Route SUBLINGUAL
Dosage form TABLET
Substance LAPINE S-100 IMMUNE GLOBULIN
Why two NDCs? The FDA registers this code as 87754-0001-1 — a 5-4-1 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 package segment → 87754-0001-01. 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.

Clinical

🧪 What is this product?

Spirudio 12 [hp_C]/U is an unapproved oral tablet meant to be placed under the tongue. Its active ingredient is lapine S-100 immune globulin, a substance derived from rabbit serum that is typically included in alternative health products intended to support immune function. This product is not approved by the FDA and is marketed outside the standard drug approval process.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87754-0001-01 You're viewing this Main listing 60 U in 1 BOTTLE 2026-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Spirudio 12 [hp_C]/Uthis 87754-0001-01 PROGRESYVUS 60 us — — FDA listed —
Spirudio 12 [hp_C]/U 87755-0001-01 Progressive 60 us — — 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
Jun 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.

What it looks like

Color white
ShapeRound
ImprintNoimprint
Size6 mm
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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.

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

The official label also statesInactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerPROGRESYVUS TYRIMAI MB
Labeler code87754
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from PROGRESYVUS TYRIMAI MB labeler code 87754

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 label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, up to 2 tablets, three times daily may be taken. Use regularly for best results.

⏱️ Dosage and Administration 68 words ▾

Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, take 2 tablets, up to three times daily. Use regularly for best results. Description Spirudio For Children is a gentle formula designed to support kids’ focus, calmness, and overall emotional balance. Safe and effective for children ages 5 and up, it works with the body to promote clarity and reduce everyday stress without harsh stimulants.

⚠️ Warnings 67 words ▾

If pregnant or breastfeeding, ask a healthcare professional before use. If symptoms persist or worsen, discontinue use and consult a healthcare professional. Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. Consult a physician before use if you have a medical condition or are taking any medication. This product is not intended to diagnose, treat, cure, or prevent any disease.

🧪 Active Ingredient 13 words ▾

Active: Targeted antibodies to S100 protein (helps regulate mood, focus, and stress response).

🧪 Inactive Ingredients 7 words ▾

Inactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate.

🎯 Purpose 50 words ▾

May help enhance: Mental clarity Concentration and attention Emotional stability May help reduce: Feelings of anxiety and stress Restlessness and irritability Impulsivity and emotional reactivity This natural formula may help you feel calmer, more focused, and better equipped to handle the demands of everyday life while supporting long-term mental well-being.

📄 Keep Out of Reach of Children 6 words ▾

keep out of reach of children

📄 Package Label / Principal Display Panel ~2 min read ▾

Adults Description Spirudio For Adults is a gentle, non-habit forming formula designed to help manage stress, improve focus, and support emotional balance in daily life. Safe for adults 18 years and older, it works with the body to promote calmness, mental clarity, and resilience without harsh stimulants or sedatives. May help enhance: Mental clarity Concentration and attention Emotional stability May help reduce: Feelings of anxiety and stress Restlessness and irritability Impulsivity and emotional reactivity This natural formula may help you feel calmer, more focused, and better equipped to handle the demands of everyday life while supporting long-term mental well-being.

Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, take 2 tablets, up to three times daily. Use regularly for best results.

Ingredients: Active: Targeted antibodies to S100 protein (supports regulation of mood, focus, and stress response). Inactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate. No artificial colors No artificial flavors Gluten-free & nut-free For Adults (18 years and older).

Non-drowsy, non-habit forming. Children Description Spirudio For Children is a gentle formula designed to support kids’ focus, calmness, and overall emotional balance. Safe and effective for children ages 5 and up, it works with the body to promote clarity and reduce everyday stress without harsh stimulants.

May help enhance: Mental clarity Concentration and attention Emotional balance May help reduce: Feelings of anxiety and stress Restlessness and hyperactivity Irritability and impulsivity A natural and non-habit forming formula that may help children feel calmer, more focused, and better equipped to handle everyday challenges. Directions: Dissolve 1 tablet, three times daily under the tongue. For stronger effects, up to 2 tablets, three times daily may be taken.

Use regularly for best results. Ingredients: Active: Targeted antibodies to S100 protein (helps regulate mood, focus, and stress response). Inactive: Lactose monohydrate, microcrystalline cellulose, magnesium stearate.

No artificial colors No artificial flavors Gluten-free & nut-free For children ages 5 and up. Non-drowsy, non-habit forming. Carton label image Carton label image 2 Carton label image 3

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

Over-the-counter (OTC) 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 PROGRESYVUS TYRIMAI MB. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PROGRESYVUS TYRIMAI MB 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 87752-0005-01 · Micelle 87754-0002-01 · PROGRESYVUS →
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.