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Insulizen Insulin Resistance Reducer, Insulin Receptor Restore, and Blood Sugar Level Balance 1 [hp_X]/1; 1 [hp_X]/1 Capsule — NDC 80353-451-01 (Billing 80353-0451-01)

by HCBIOPHARM LLC · 1 BOTTLE in 1 BOX / 1 CAPSULE in 1 BOTTLE / 60 CAPSULE in 1 CAPSULE

This is a package of Insulizen Insulin Resistance Reducer, Insulin Receptor Restore, and Blood Sugar Level Balance 1 [hp_X]/1; 1 [hp_X]/1 Capsule from HCBIOPHARM LLC, marketed since Nov 2021 and currently FDA-listed. It is this product's only package size.

NDC 80353-0451-01
🏷️ FDA NDC (as labeled) 80353-451-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80353-451-01
Product NDC 80353-451
11-digit billing NDC 80353045101
UNII OUK5B3W9E4, 7829X3G2X5
SPL Set ID d10353a9-0543-831e-e053-2a95a90a4e91
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-24
Route ORAL
Dosage form CAPSULE
Substance LAGERSTROEMIA SPECIOSA LEAF; MORINDA CITRIFOLIA FRUIT
Why two NDCs? The FDA registers this code as 80353-451-01 — 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 → 80353-0451-01. 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?

This is an unapproved homeopathic oral capsule containing lagerstroemia speciosa leaf and morinda citrifolia fruit. In homeopathic practice, these plant materials are traditionally used for purposes related to blood sugar and metabolic support, though homeopathic products are not evaluated by the FDA for effectiveness. The product is marketed based on homeopathic tradition rather than clinical evidence. Homeopathic remedies are highly diluted substances prepared according to homeopathic methods.

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
80353-0451-01 You're viewing this Main listing 1 BOTTLE in 1 BOX / 1 CAPSULE in 1 BOTTLE / 60 CAPSULE in 1 CAPSULE 2021-11-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Insulizen 1 [hp_X]/1; 1 [hp_X]this 80353-0451-01 HCBIOPHARM 1 capsule — — 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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
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.

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 W5488JUO8U
    A plant extract from turmeric root used as a natural colorant and flavoring agent in medicines. It provides yellow-to-orange color and mild spice flavor to tablets, capsules, and liquids.
  • UNII L878N1L0AR
    A plant extract from the bark of the eucommia tree, used in some formulations as a thickening or binding agent to help hold the medicine together and control how it dissolves.
  • UNII UA63Y8U89U
    A plant extract from bitter melon fruit used as a natural flavoring and coloring agent in medicines. It may also help preserve the product and improve its taste.
  • UNII SV6B76DK9N
    Morus alba root bark is a plant-derived ingredient from white mulberry. It acts as a binder and natural colorant, helping hold tablet ingredients together and contribute to the product's appearance.
  • UNII 1693AM5SBN
    Salvia miltiorrhiza root is a plant extract used in traditional medicine formulations. It may serve as a flavoring agent, natural colorant, or functional ingredient to support the product's intended therapeutic profile.

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

The official label also statesTurmeric (Curcuma longa), Eucommia (Eucommia ulmoides) Bark, White Mulberry (Morus alba) Root Bark, Bitter Melon (Momordica charantia) Fruit, Red Sage (Salvia miltiorrhiza) Root

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

LabelerHCBIOPHARM LLC
Labeler code80353
First marketedNov 2021
Product typeHuman Otc Drug
Portfolio6 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.

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 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Use To reduce insulin resistance To restore defective insulin receptors To maintain a normal blood sugar level

⏱️ Dosage and Administration 10 words ▾

Directions Take two (2) capsules daily 1 hour before breakfast.

⚠️ Warnings 14 words ▾

Warning Individuals with known medical conditions should consult a doctor prior to using this.

🧪 Active Ingredient 10 words ▾

Active Ingredients Lagerstroemia speciosa Leaf 1X, Morinda citrifolia Fruit 1X

🧪 Inactive Ingredients 25 words ▾

Inactive Ingredients Turmeric (Curcuma longa), Eucommia (Eucommia ulmoides) Bark, White Mulberry (Morus alba) Root Bark, Bitter Melon (Momordica charantia) Fruit, Red Sage (Salvia miltiorrhiza) Root

🎯 Purpose 15 words ▾

Purpose Reduces insulin resistance, restores defective insulin receptors, and maintains a normal blood sugar level*

📄 Keep Out of Reach of Children 12 words ▾

Keep Out of Reach of Children Keep out of reach of children

📄 Other Information 31 words ▾

Other Information Do not use if seal is broken. Do not eat freshness packet enclosed. Keep product out of direct sunlight, high temperature, and humidity. Store in a cool, dry place.

📄 Package Label / Principal Display Panel 18 words ▾

Package Label Display Insulizen INSULIN RESISTANCE REDUCER INSULIN RECEPTOR RESTORE BLOOD SUGAR LEVEL BALANCE Homeopathic 60 Capsules insulizen

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 Homeopathic listing

About homeopathic listings

Insulizen Insulin Resistance Reducer, Insulin Receptor Restore, and Blood Sugar Level Balance 1 [hp_X]/1; 1 [hp_X]/1 CAPSULE is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 — Not published for this NDC No photo available yet for this listing.
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 Homeopathic". 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 HCBIOPHARM LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HCBIOPHARM 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 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.
← 80353-0196-01 · HCBIOPHARM 80353-0551-01 · HCBIOPHARM →
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.