NDC 65162-995 Dotti

Estradiol

NDC Product Code 65162-995

NDC Product Information

Dotti with NDC 65162-995 is a a human prescription drug product labeled by Amneal Pharmaceuticals Llc. The generic name of Dotti is estradiol. The product's dosage form is patch, extended release and is administered via transdermal form.

Labeler Name: Amneal Pharmaceuticals Llc

Dosage Form: Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat 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.


Dotti Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ESTRADIOL .075 mg/d

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the 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.

  • DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S) (UNII: 83D19O7250)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • POVIDONE (UNII: FZ989GH94E)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S) (UNII: 83D19O7250)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • POVIDONE (UNII: FZ989GH94E)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S) (UNII: 83D19O7250)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • POVIDONE (UNII: FZ989GH94E)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S) (UNII: 83D19O7250)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • POVIDONE (UNII: FZ989GH94E)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)

Administration Route(s)

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

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Pharmacological Class(es)

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

  • Estradiol Congeners - [CS]
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amneal Pharmaceuticals Llc
Labeler Code: 65162
FDA Application Number: ANDA211293 Additional informationCallout TooltipWhat 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat 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: 02-04-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Dotti Product Label Images