NDC 0052-0603-02 Bcg Vaccine

Bacillus Calmette-guerin Substrain Tice Live Antigen

NDC Package Code 0052-0603-02

The NDC Code 0052-0603-02 is assigned to a package of 1 vial in 1 carton > 1 injection, powder, lyophilized, for solution in 1 vial (0052-0603-01) of Bcg Vaccine, a vaccine lable labeled by Organon Usa Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via percutaneous form.

Field Name	Field Value
NDC Code	0052-0603-02
Package Description	1 VIAL in 1 CARTON > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01)
Proprietary Name	Bcg Vaccine 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.
Non-Proprietary Name	Bacillus Calmette-guerin Substrain Tice Live Antigen 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.
11-Digit NDC Billing Format	00052060302 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.
Product Type	Vaccine 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.
Labeler Name	Organon Usa Inc.
Dosage Form	Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s)	Percutaneous - Administration through the skin.
Active Ingredient(s)	BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/1
Pharmacological Class(es)	Live Attenuated Bacillus Calmette-Guerin Vaccine - [EPC] (Established Pharmacologic Class) Actively Acquired Immunity - [PE] (Physiologic Effect) Vaccines - Attenuated - [CS] BCG Vaccine - [CS] Live Attenuated Bacillus Calmette-Guerin Immunotherapy - [EPC] (Established Pharmacologic Class) Increased Macrophage Proliferation - [PE] (Physiologic Effect) Increased Immunologically Active Molecule Activity - [PE] (Physiologic Effect)
Sample Package	No Sample Package? This field Indicates whether this package is a sample packaging or not.
Marketing Category	BLA - A product marketed under an approved Biologic License 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	BLA103050 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	06-21-1989 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	12-31-2020 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	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. Values = ‘Y’ or ‘N’.

NDC Code Structure

0052 - Organon Usa Inc.
- 0052-0603 - Bcg Vaccine
  - 0052-0603-02 - 1 VIAL 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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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0052-0603-02 HCPCS crosswalk information with package details and bill units information.

NDC Billing Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
00052060302	90585	Bcg vaccine percut	50 MG	1	1	1	1
00052060302	90586	Bcg vaccine intravesical	1 EACH	1	1	1	1
00052060302	J9030	Bcg live intravesical 1mg	1 EA	1	1	50	50

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