Topiramate


Aurobindo Pharma Limited
Human Prescription Drug
NDC 65862-171
Topiramate is a drug for further processing labeled by 'Aurobindo Pharma Limited'. National Drug Code (NDC) number for Topiramate is 65862-171. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Topiramate drug includes Topiramate - 25 mg/1 . The currest status of Topiramate drug is Active.

Drug Information:

Drug NDC: 65862-171
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Topiramate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Topiramate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Aurobindo Pharma Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Film Coated
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:TOPIRAMATE - 25 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 27 Mar, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 23 Dec, 2024
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.
Application Number: ANDA078462
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.
Listing Expiration Date: 31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Aurobindo Pharma Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:151226
199888
199889
199890
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0365862171603
0365862173607
0365862172600
UPC stands for Universal Product Code.
NUI:N0000008486
N0000185506
N0000182140
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:0H73WJJ391
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Cytochrome P450 3A4 Inducers [MoA]
Cytochrome P450 2C19 Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class PE:Decreased Central Nervous System Disorganized Electrical Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:Cytochrome P450 2C19 Inhibitors [MoA]
Cytochrome P450 3A4 Inducers [MoA]
Decreased Central Nervous System Disorganized Electrical Activity [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
65862-171-05500 TABLET, FILM COATED in 1 BOTTLE (65862-171-05)11 Apr, 2022N/ANo
65862-171-6060 TABLET, FILM COATED in 1 BOTTLE (65862-171-60)27 Mar, 2009N/ANo
65862-171-991000 TABLET, FILM COATED in 1 BOTTLE (65862-171-99)11 Apr, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Comments/ Reviews:

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