The NDC Code 0115-1529-08 is assigned to a package of 3 blister pack in 1 carton > 10 tablet, orally disintegrating in 1 blister pack (0115-1529-15) of Lamotrigine, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet, orally disintegrating and is administered via oral form.
The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 0115-1529-08 is $6.52972 and is up-to-date as of 08-28-2019.
||3 BLISTER PACK in 1 CARTON > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0115-1529-15)
||Lamotrigine 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.
||Lamotrigine 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.
||Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug. It is thought to work by restoring the balance of certain natural substances in the brain. This drug is not approved for use in children younger than 2 years due to an increased risk of side effects (such as infections).
|11-Digit NDC Billing Format
||00115152908 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
||EA - Billing unit of "each" is used when the product is dispensed in discreet units.
|RxNorm Crosswalk||103968, 198430, 252478 and 252479 - RxCUIs What is RxNorm?|
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
||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.
Amneal Pharmaceuticals Of New York Llc
||Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
- Oral - Administration to or by way of the mouth.
- Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
- Mood Stabilizer - [EPC] (Established Pharmacologic Class)
- Anti-epileptic Agent - [EPC] (Established Pharmacologic Class)
||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
||ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
|FDA Application Number
||ANDA200828 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.
|Start Marketing Date
||01-09-2015 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.
||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 ("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".
NDC Code Structure
- 0115 - Amneal Pharmaceuticals Of New York Llc
- 0115-1529 - Lamotrigine
0115-1529-08 - 3 BLISTER PACK in 1 CARTON
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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