Aplicare Povidone-iodine
NDC 52380-0001

View NDC Profile RxNorm Concepts.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 52380-0001?
  4. Aplicare Povidone-iodine Uses
  5. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Aplicare Povidone-iodine is a OTC MONOGRAPH DRUG-approved product labeled by Aplicare Products, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 52380-0001 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
52380-0001
Proprietary Name:
Aplicare Povidone-iodine
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Aplicare Products, Llc
Labeler Code:
52380
Product Label ID:
6e04f24a-a4ca-4e84-b3b3-7deba0b9cad0
FDA Application Number: [6]
M003
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
03-01-1984
End Marketing Date: [10]
05-31-2025
Listing Expiration Date: [11]
05-31-2025
Exclude Flag: [12]
D

Code Structure Chart

Product Details

What is NDC 52380-0001?

The NDC code 52380-0001 is assigned by the FDA to the product Aplicare Povidone-iodine. This pharmaceutical product is labeled by Aplicare Products, Llc and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 52380-0001-1, 52380-0001-3, 52380-0001-5. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Indications and UsageEpinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia. INDICATIONS AND USAGELidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. <paragraph>INDICATIONS AND USAGEMARCAINE Spinal is indicated for the production of subarachnoid block (spinal anesthesia).Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of spinal anesthesia.

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? 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.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".