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Orostat 8% EPINEPHRINE HYDROCHLORIDE 1200 mg/15mL Solution, 15 mL — NDC 10129-0006-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Orostat 8% EPINEPHRINE HYDROCHLORIDE 1200 mg/15mL Solution, 15 mL — NDC 10129-006-02 (Billing 10129-0006-02)

by Gingi-Pak a Division of the Belport · 15 mL in 1 BOTTLE, GLASS

This is a package of 15 mL of Orostat 8% EPINEPHRINE HYDROCHLORIDE 1200 mg/15mL Solution from Gingi-Pak a Division of the Belport, marketed since Apr 1990 and currently FDA-listed. It is this product's only package size.

NDC 10129-0006-02
🏷️ FDA NDC (as labeled) 10129-006-02 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) 10129-006-02
Product NDC 10129-006
11-digit billing NDC 10129000602
UNII WBB047OO38
SPL Set ID 755005b8-165b-b667-e053-2991aa0a3651
Established class (EPC) Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Agonists
Chemical class Catecholamines
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-04-04
Route DENTAL, PERIODONTAL, SUBGINGIVAL
Dosage form SOLUTION
Substance EPINEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 10129-006-02 — 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 → 10129-0006-02. 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

📗 Our plain-language guide HelloPharmacist
  • Epinephrine works fast but wears off quickly — sometimes in as little as 15 to 20 minutes. Anaphylaxis can come back (this is called a biphasic reaction), and you may need addition...
  • Why do I need to go to the ER after using my EpiPen or Auvi-Q if I already feel better?
  • Yes, it absolutely matters. Inject into the outer thigh — you can even go through your clothing if needed. Never inject into the buttocks (that spot carries a risk of serious infec...
  • Where exactly do I inject it, and does it matter?
📖 Read our full Epinephrine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Epinephrine Hydrochloride — tap one for details:

Butcher's BroomModerate
🌿 Every supplement checked against Epinephrine Hydrochloride (1 interactions) — ranked by severity →
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 mLPer 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
10129-0006-02 You're viewing this Main listing 15 mL in 1 BOTTLE, GLASS 1990-04-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Orostat 8% 1200 mg/15mLthis 10129-0006-02 Gingi-Pak 15 ml — — 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

🏛️
1990
On the market since
Apr 1990
📍
2026
Currently FDA-listed
36 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.

  • 0.15 mL / 15 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 1.995 mg / 15 mL UNII 9G34HU7RV0
    EDTA is a chemical compound that binds to metals and other substances in medicines. It's used as a preservative and stabilizer to prevent discoloration and extend shelf life.
  • 10.05 mg / 15 mL UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 4.95 mg / 15 mL UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 49.5 mg / 15 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 37.5 mg / 15 mL UNII 2K5B8F6ES1
    Sodium dithionite is a white crystalline powder that acts as a reducing agent and antioxidant in medications. It helps prevent oxidation and degradation of active ingredients, extending the product's shelf life and stability.
  • 37.5 mg / 15 mL UNII KH7I04HPUU
    A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
  • 15 mg / 15 mL UNII HX1032V43M
    Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.

8 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.

Manufacturer & labeler

LabelerGingi-Pak a Division of the Belport
Labeler code10129
First marketedApr 1990
Product typeHuman Otc Drug
Portfolio14 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 2 words ▾

Uses Uses

⏱️ Dosage and Administration 2 words ▾

Directions Directions

⚠️ Warnings 2 words ▾

Warnings Warnings

📦 Storage and Handling 2 words ▾

Storage Storage

🧪 Active Ingredient 4 words ▾

Active Ingredient Active Ingredient

🧪 Inactive Ingredients 4 words ▾

Inactive Ingredient Inactive ingredients

🎯 Purpose 2 words ▾

Purpose Purpose

📋 Description 2 words ▾

Description Description

📄 Stop Use and Ask a Doctor If 6 words ▾

Do not use Do not use

📄 Keep Out of Reach of Children 12 words ▾

Keep out of reach if children Keep out of reach if children

📄 Package Label / Principal Display Panel 6 words ▾

Principal Display-Orostat 8% Principal Display-Orostat 8%

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Orostat 8% (this brand).

Top reported reactions

Loss Of Personal Independence In Daily Activities122
Headache106
Dyspnoea103
Rash101
Pyrexia91
Pain88
Fatigue85

Age at onset

Neonate3
Infant2
Child7
Adolescent6
Adult61
Elderly43

Reporter sex

461 reports
Male · 52%
Female · 48%

Serious outcomes

Hospitalization168
Life-threatening77
Death38
Disabling15
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 62 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Gingi-Pak a Division of the Belport. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gingi-Pak a Division of the Belport 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.
← 10122-0901-12 · Chiesi 10129-0017-02 · Gingi-Pak →
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.