NDC 0071-1019-68 Lyrica

Pregabalin

NDC Package Code 0071-1019-68

Field Name Field Value
NDC Code 0071-1019-68
Package Description 90 CAPSULE in 1 BOTTLE
Proprietary Name Lyrica Additional informationCallout TooltipWhat 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.
Non-Proprietary Name Pregabalin Additional informationCallout TooltipWhat 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.
11-Digit NDC Billing Format 00071101968 Additional informationCallout TooltipNDC 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.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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.
Labeler Name Parke-davis Div Of Pfizer Inc
Dosage Form Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • PREGABALIN 225 mg/1
Sample Package No Additional informationCallout TooltipSample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved 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.
FDA Application Number NDA021446 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.
Start Marketing Date 12-30-2004 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 12-31-2019 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.

The NDC Code 0071-1019-68 is assigned to Lyrica, a human prescription drug labeled by Parke-davis Div Of Pfizer Inc. The product's dosage form is capsule and is administered via oral form.


Code Structure
  • 0071 - Parke-davis Div Of Pfizer Inc
    • 0071-1019 - Lyrica
      • 0071-1019-68 - 90 CAPSULE in 1 BOTTLE

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.

* Please review the disclaimer below.

Pill Identification

pregabalin 225 MG Oral Capsule [Lyrica]

pregabalin 225 MG Oral Capsule [Lyrica]
Image Labeler: Parke-Davis Div of Pfizer Inc

Physical Characteristics

What does lyrica look like?
Lyrica may look like a orange, white capsule shaped capsule; approximately 19 millimeters in size. The medicine is imprinted with black printed code(s) Pfizer and PGN and 225.

Shape: CAPSULE
Size: 19 mm
Color: ORANGE, WHITE
Imprint: Pfizer;PGN;225
Imprint Color: BLACK
Imprint Type: PRINTED

Active and Inactive Ingredients

Active Ingredients: pregabalin 225 mg

Inactive Ingredients: lactose monohydrate, starch, corn, talc, gelatin, titanium dioxide, sodium lauryl sulfate, silicon dioxide, ferric oxide red, shellac, ferrosoferric oxide, propylene glycol, potassium hydroxide

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