Primatene Mist
Epinephrine Inhalation
Armstrong Pharmaceuticals, Inc.
Human Otc Drug
NDC 17270-553Primatene Mist also known as Epinephrine Inhalation is a human otc drug labeled by 'Armstrong Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Primatene Mist is 17270-553. This drug is available in dosage form of Aerosol. The names of the active, medicinal ingredients in Primatene Mist drug includes Epinephrine - 125 ug/1 . The currest status of Primatene Mist drug is Active.
Drug Information:
| Drug NDC: | 17270-553 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Primatene Mist |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Epinephrine Inhalation |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Armstrong Pharmaceuticals, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | EPINEPHRINE - 125 ug/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 14 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA205920 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Armstrong Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2109083
2109088
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000000209
N0000000245
N0000175552
N0000175555
N0000175570
M0003647
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | YKH834O4BH
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Adrenergic alpha-Agonists [MoA]
Adrenergic beta-Agonists [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | alpha-Adrenergic Agonist [EPC]
beta-Adrenergic Agonist [EPC]
Catecholamine [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Catecholamines [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [MoA]
Adrenergic beta-Agonists [MoA]
Catecholamine [EPC]
Catecholamines [CS]
alpha-Adrenergic Agonist [EPC]
beta-Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 17270-553-00 | 1 INHALER in 1 CARTON (17270-553-00) / 160 AEROSOL in 1 INHALER | 14 Dec, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose bronchodilator
Product Elements:
Primatene mist epinephrine inhalation epinephrine epinephrine alcohol norflurane polysorbate 80 thymol
Indications and Usage:
Uses for temporary relief of mild symptoms of intermittent asthma â wheezing â tightness of chest â shortness of breath
Warnings:
Warnings for oral inhalation only asthma alert: because asthma may be life threatening, see a doctor if you â are not better in 20 minutes â get worse â need more than 8 inhalations in 24 hours â have more than 2 asthma attacks in a week these may be signs that your asthma is getting worse. do not use â unless a doctor said you have asthma â if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs taken for depression, psychiatric or emotional conditions, or parkinsonâs 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 a pharmacist before taking this product. ask a doctor before use if you have â ever been hospitalized for asthma â heart disease â high blood pressure â diabetes â trouble urinating due to an enlarged prostate gland â thyroid disease â seizures â narrow angle glaucoma ask a doctor or p
Read more...harmacist before use if you are â taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions â taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) when using this product â your blood pressure or heart rate may go up. this could increase your risk of heart attack or stroke, which may cause death. â your risk of heart attack or stroke increases if you: â have a history of high blood pressure or heart disease â take this product more frequently or take more than the recommended dose. â avoid foods or beverages that contain caffeine â avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect â avoid spraying in eyes â contents under pressure. do not puncture or incinerate. â do not store near open flame or heat above 120°f (49°c). may cause bursting. stop use and ask a doctor if â your asthma is getting worse (see asthma alert) â you have difficulty sleeping â you have a rapid heart beat â you have tremors, nervousness, or seizure if pregnant or breast-feeding , ask a health care professional before use keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for oral inhalation only asthma alert: because asthma may be life threatening, see a doctor if you â are not better in 20 minutes â get worse â need more than 8 inhalations in 24 hours â have more than 2 asthma attacks in a week these may be signs that your asthma is getting worse. do not use â unless a doctor said you have asthma â if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs taken for depression, psychiatric or emotional conditions, or parkinsonâs 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 a pharmacist before taking this product. ask a doctor before use if you have â ever been hospitalized for asthma â heart disease â high blood pressure â diabetes â trouble urinating due to an enlarged prostate gland â thyroid disease â seizures â narrow angle glaucoma ask a doctor or pharmacist before use if you are â taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions â taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain) when using this product â your blood pressure or heart rate may go up. this could increase your risk of heart attack or stroke, which may cause death. â your risk of heart attack or stroke increases if you: â have a history of high blood pressure or heart disease â take this product more frequently or take more than the recommended dose. â avoid foods or beverages that contain caffeine â avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect â avoid spraying in eyes â contents under pressure. do not puncture or incinerate. â do not store near open flame or heat above 120°f (49°c). may cause bursting. stop use and ask a doctor if â your asthma is getting worse (see asthma alert) â you have difficulty sleeping â you have a rapid heart beat â you have tremors, nervousness, or seizure if pregnant or breast-feeding , ask a health care professional before use keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product â your blood pressure or heart rate may go up. this could increase your risk of heart attack or stroke, which may cause death. â your risk of heart attack or stroke increases if you: â have a history of high blood pressure or heart disease â take this product more frequently or take more than the recommended dose. â avoid foods or beverages that contain caffeine â avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect â avoid spraying in eyes â contents under pressure. do not puncture or incinerate. â do not store near open flame or heat above 120°f (49°c). may cause bursting.
Dosage and Administration:
Directions â read the consumer information insert for detailed directions on how to use this product â do not use more than directed â for adults and children 12 years of age and over â children under 12 years of age: do not use; it is not known if the drug works or is safe in children under 12 before first use (new inhaler) activate new inhaler by shaking then spraying into air 4 separate times each time you dose â remove red cap (if attached) â shake then spray into the air 1 time â exhale completely, place inhaler in mouth â inhale deeply while pressing down on top of inhaler, then continue the deep breath â hold breath as long as possible, exhale â wait 1 minute. if symptoms not relieved, take a second inhalation by repeating steps above. after use â wait at least 4 hours between doses â do not use more than 8 inhalations in 24 hours â wash inhaler after each day of use. run water through the mouthpiece for 30 seconds
Read more....
Stop Use:
Stop use and ask a doctor if â your asthma is getting worse (see asthma alert) â you have difficulty sleeping â you have a rapid heart beat â you have tremors, nervousness, or seizure
Package Label Principal Display Panel:
Primatene mist® carton principal display panel text: primatene mist® epinephrine inhalation aerosol 0.125 mg per spray bronchodilator for oral inhalation only for temporary relief of mild symptoms of intermittent asthma suspension: shake then spray into the air before each inhalation. this item is electronically protected new formulation: see important usage information on insert and on side panels 160 metered sprays net weight: 11.7g carton
Further Questions:
Questions or comments? call 1-8 primatene or 1-877-462-8363 mon.- fri. 7 am - 5 pm pst