NDC 51662-1378 Atropine Sulfate
Atropine Sulfate
NDC Product Code 51662-1378
NDC Code: 51662-1378
Proprietary Name: Atropine Sulfate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Atropine Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
NDC Code Structure
- 51662 - Hf Acquisition Co Llc, Dba Healthfirst
- 51662-1378 - Atropine Sulfate
NDC 51662-1378-1
Package Description: 1 SYRINGE in 1 BOX > 10 mL in 1 SYRINGE
NDC Product Information
Atropine Sulfate with NDC 51662-1378 is a a human prescription drug product labeled by Hf Acquisition Co Llc, Dba Healthfirst. The generic name of Atropine Sulfate is atropine sulfate. The product's dosage form is injection and is administered via parenteral form.
Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Atropine Sulfate Active Ingredient(s)
What is the Active Ingredient(s) List?This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Parenteral - Administration by injection, infusion, or implantation.
Pharmacological Class(es)
What is a Pharmacological Class?These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.
- Anticholinergic - [EPC] (Established Pharmacologic Class)
- Cholinergic Antagonists - [MoA] (Mechanism of Action)
- Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
- Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Labeler Code: 51662
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
Start Marketing Date: 10-15-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.
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