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  4. NDC Product Code: 73377-084 Tofacitinib Citrate

NDC 73377-084 Tofacitinib Citrate

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 73377-084?
  4. Tofacitinib Citrate Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Get all the details for National Drug Code (NDC) 73377-084 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
73377-084
Proprietary Name:
Tofacitinib Citrate
Non-Proprietary Name: [1]
Tofacitinib Citrate
Substance Name: [2]
Tofacitinib Citrate
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Ax Pharmaceutical Corp
Labeler Code:
73377
Marketing Category: [8]
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date: [9]
11-03-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Code Structure Chart

Product Details

What is NDC 73377-084?

The NDC code 73377-084 is assigned by the FDA to the UNFINISHED product Tofacitinib Citrate which is a bulk ingredient product labeled by Ax Pharmaceutical Corp. The generic name of Tofacitinib Citrate is tofacitinib citrate. The product's dosage form is powder. The product is distributed in 10 packages with assigned NDC codes 73377-084-01 500 g in 1 jar , 73377-084-02 100 g in 1 jar , 73377-084-03 10 g in 1 jar , 73377-084-04 50 g in 1 jar , 73377-084-05 5 g in 1 jar , 73377-084-06 1000 g in 1 package , 73377-084-07 9.1 g in 1 jar , 73377-084-08 40 g in 1 package , 73377-084-09 1120 g in 1 jar , 73377-084-10 8.5 g in 1 jar . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Tofacitinib Citrate?

Tofacitinib is used to treat certain types of arthritis (such as psoriatic arthritis, rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis-pcJIA). It helps to decrease pain/tenderness/swelling in the joints. Tofacitinib is also used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain.

What are Tofacitinib Citrate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] 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.

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

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.