Home › NDC Lookup › Ingredients › Ephedrine Hydrochloride › 80070-0600-60
Primatene EPHEDRINE HYDROCHLORIDE 12.5 mg Tablet, 60-count — NDC 80070-0600-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Primatene EPHEDRINE HYDROCHLORIDE 12.5 mg Tablet, 60-count — NDC 80070-600-60 (Billing 80070-0600-60)

by Foundation Consumer Brands · 5 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK

This is a package of 60 tablets of Primatene EPHEDRINE HYDROCHLORIDE 12.5 mg Tablet from Foundation Consumer Brands, marketed since Jan 2021 and currently FDA-listed.

NDC 80070-0600-60
🏷️ FDA NDC (as labeled) 80070-600-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Product page 80070-0600-24 Also comes in: 24 tablets 80070-600-24
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

NDC database record

One package, one record: these facts belong to NDC 80070-600-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
80070 labeler · 600 product · 60 package
Package marketed since
Jan 22, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8007060060 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80070-600-60
Product NDC 80070-600
11-digit billing NDC 80070060060
RxCUI 2534871, 2591390
UNII NLJ6390P1Z
Application # M012
SPL Set ID 2170f081-c03f-47e8-bc63-4052c5e653fa
Established class (EPC) Norepinephrine Releasing Agent; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Agonists
Physiologic effect Increased Norepinephrine Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-22
Route ORAL
Dosage form TABLET
Substance EPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2534871
Why two NDCs? The FDA registers this code as 80070-600-60 — 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 → 80070-0600-60. 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.

RxNorm drug class

This medicine belongs to the alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Norepinephrine Releasing Agent
Drug family (ATC) Adrenergic and dopaminergic agents, Sympathomimetics, plain, Alpha- and beta-adrenoreceptor agonists
How it works Adrenergic alpha-Agonists, Adrenergic beta-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The injection treats dangerously low blood pressure during anesthesia and is given by trained providers. Certain tablets, such as Bronkaid and Primatene,...
  • Adults and children 12 and over take them about every 4 hours as needed, and there is a daily limit on the package. Don't take more than directed. Children under 12 shouldn't use B...
  • The most common are nausea, vomiting and a fast heartbeat. Some people feel dizzy, restless or notice a thumping heartbeat. If you have a rapid heartbeat, tremors, nervousness, tro...
  • Check with me first. Don't use the tablets with a prescription MAOI or within 2 weeks of stopping one. Also tell me if you take other products with ephedrine, pseudoephedrine, phen...
📖 Read our full Ephedrine guide →
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.
Try another pack size: 24 tablets
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
80070-0600-24 80070-600-24 Main listing 2 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2021-01-22 — Active
80070-0600-60 You're viewing this 5 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2021-01-22 — Active

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 5 blister pack in 1 carton / 12 tablet in 1 blister pack.
How does this package differ from NDC 80070-0600-24?
Both are Primatene EPHEDRINE HYDROCHLORIDE 12.5 mg Tablet — the drug itself is identical. This page's package is the 60-count one, while NDC 80070-0600-24 is the 24 tablets package.
What NDC number is used to bill for this package of Primatene EPHEDRINE HYDROCHLORIDE 12.5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ephedrine Hydrochloride 12.5 mg 00363-9812-07 Walgreen 60 tablets — — FDA listed —
Primatene 12.5 mgthis 80070-0600-60 Foundation 60 tablets — — 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
Jan 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.

What it looks like

Color yellow
ShapeRound
ImprintPT;in;circle;engraved
Size8 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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesD&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

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

LabelerFoundation Consumer Brands
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code80070
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from Foundation Consumer Brands labeler code 80070

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Use for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath

⏱️ Dosage and Administration 41 words ▾

Directions do not take more than directed adults and children 12 years and over: take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings ~2 min read ▾

Warnings Asthma alert Because asthma may be life threatening, see a doctor if you are not better in 60 minutes get worse need more than 12 tablets in 24 hours use more than 8 tablets in 24 hours for 3 or more days a week have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. This product will not give you asthma relief as quickly as an inhaled bronchodilator. Do not use unless a doctor said you have asthma if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) When using this product your blood pressure or heart rate may go up.

This could increase your risk of heart attack or stroke, which may cause death. your risk of heart attack or stroke increases if you: have a history of high blood pressure or heart disease take this product more frequently or take more than the recommended dose avoid foods or beverages that contain caffeine avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect Stop use and ask a doctor if your asthma is getting worse (see Asthma alert ) you have difficulty sleeping you have a rapid heart beat you have tremors, nervousness, or seizure If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 6 words ▾

Other information store at 20-25°C (68-77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Ephedrine HCl 12.5 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

🎯 Purpose 2 words ▾

Purpose Bronchodilator

📄 Do Not Use 79 words ▾

Do not use unless a doctor said you have asthma if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 38 words ▾

Ask a doctor before use if you have ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 41 words ▾

Ask a doctor or pharmacist before use if you are taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

📄 When Using This Product 79 words ▾

When using this product your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. your risk of heart attack or stroke increases if you: have a history of high blood pressure or heart disease take this product more frequently or take more than the recommended dose avoid foods or beverages that contain caffeine avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if your asthma is getting worse (see Asthma alert ) you have difficulty sleeping you have a rapid heart beat you have tremors, nervousness, or seizure

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 12 words ▾

Questions or comments? Call 1-800-535-0026 weekdays 9 AM to 5 PM EST

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton NEW FORMULA Primatene ® TABLETS Ephedrine HCl 12.5 mg • Bronchodilator For the Temporary Relief of Mild Symptoms of INTERMITTENT ASTHMA 24 TABLETS PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton

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 Primatene (this brand).

Top reported reactions

Hypotension31
Dyspnoea24
Cardiac Arrest23
Nausea21
Blood Pressure Decreased19
Tachycardia19
Anaphylactic Reaction18

Age at onset

Infant3
Adolescent2
Adult25
Elderly13

Reporter sex

446 reports
Male · 48%
Female · 52%

Serious outcomes

Hospitalization173
Life-threatening69
Death66
Disabling12
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 53 9
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
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 "Otc Monograph Drug". 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 Foundation Consumer Brands. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 24 tablets (80070-0600-24). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Foundation Consumer Brands 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.
← 80070-0500-14 · Foundation 80136-0063-11 · Heartland →
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.