NDC 45861-107-01 Active-medicated Specimen Collection Kit

NDC Package Code 45861-107-01

The NDC Code 45861-107-01 is assigned to a package of 1 kit in 1 package * 1 tablet in 1 package (68071-097-01) * 3 ml in 1 packet * 1 in 1 package of Active-medicated Specimen Collection Kit, labeled by Pharmaceutica North America, Inc. The product's dosage form is and is administered via form.

Field Name Field Value
NDC Code 45861-107-01
Package Description 1 KIT in 1 PACKAGE * 1 TABLET in 1 PACKAGE (68071-097-01) * 3 mL in 1 PACKET * 1 in 1 PACKAGE
Proprietary Name Active-medicated Specimen Collection Kit 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.
11-Digit NDC Billing Format 45861010701 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.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk1038558 and 310429 - 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.
Labeler Name Pharmaceutica North America, Inc
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Start Marketing Date 10-31-2013 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 12-31-2017 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.
Exclude Flag I 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".
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Code Structure

  • 45861 - Pharmaceutica North America, Inc
    • 45861-107 - Active-medicated Specimen Collection Kit
      • 45861-107-01 - 1 KIT in 1 PACKAGE * 1 TABLET in 1 PACKAGE (68071-097-01) * 3 mL in 1 PACKET * 1 in 1 PACKAGE

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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