NDC 0093-9020 Cyclosporine Modified
Capsule, Liquid Filled Oral

Product Information

Cyclosporine Modified is a human prescription drug product labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is capsule, liquid filled and is administered via oral form.

Product Code0093-9020
Proprietary Name 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.
Cyclosporine Modified
Non-Proprietary Name 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.
Cyclosporine
Product Type 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.
Human Prescription Drug
Dosage FormCapsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Teva Pharmaceuticals Usa, Inc.
Labeler Code0093
FDA Application Number 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.
ANDA065110
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-08-2021
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Cyclosporine Modified?


Product Characteristics

Color(s)YELLOW (C48330)
YELLOW (C48330 - OCHRE-YELLOW)
BROWN (C48332)
ShapeOVAL (C48345)
CAPSULE (C48336)
Size(s)13 MM
21 MM
25 MM
Imprint(s)25;MG
50;MG
100;MG
Score1

Product Packages

NDC 0093-9020-65

Package Description: 30 BLISTER PACK in 1 CARTON > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9020-19)

Price per Unit: $1.42485 per EA

Product Details

What are Cyclosporine Modified 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.
  • CYCLOSPORINE 100 mg/1 - A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).

NDC to RxNorm Crosswalk

What is RxNorm? 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:

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • ALCOHOL (UNII: 3K9958V90M)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
  • POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ALCOHOL (UNII: 3K9958V90M)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
  • POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ALCOHOL (UNII: 3K9958V90M)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
  • POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)
  • ALCOHOL (UNII: 3K9958V90M)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ALCOHOL (UNII: 3K9958V90M)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ALCOHOL (UNII: 3K9958V90M)
  • .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • BROWN IRON OXIDE (UNII: 1N032N7MFO)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Cyclosporine Modified Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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* Please review the disclaimer below.