NDC 71384-509 Moxifloxacin Pf

Moxifloxacin Pf

NDC Product Code 71384-509

NDC 71384-509-01

Package Description: 20 VIAL, SINGLE-DOSE in 1 BOX > 1 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Moxifloxacin Pf with NDC 71384-509 is a a human prescription drug product labeled by Imprimis Njof, Llc. The generic name of Moxifloxacin Pf is moxifloxacin pf. The product's dosage form is injection, solution and is administered via ophthalmic form.

Labeler Name: Imprimis Njof, Llc

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

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.

Moxifloxacin Pf 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.

  • MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 5 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Quinolone Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Quinolones - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Imprimis Njof, Llc
Labeler Code: 71384
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: 02-10-2020 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: 12-31-2021 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’.

* Please review the disclaimer below.

Moxifloxacin Pf Product Label Images

Moxifloxacin Pf Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Storage And Handling

Store at 20° to 25° C (68° to 77° F)

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