NDC 59676-580 Janssen Covid-19 Vaccine

Jnj-78436735

NDC Product Code 59676-580

NDC 59676-580-05

Package Description: 10 VIAL, MULTI-DOSE in 1 CARTON > 2.5 mL in 1 VIAL, MULTI-DOSE (59676-580-15)

NDC Product Information

Janssen Covid-19 Vaccine with NDC 59676-580 is a a vaccine lable product labeled by Janssen Products, Lp. The generic name of Janssen Covid-19 Vaccine is jnj-78436735. The product's dosage form is suspension and is administered via intramuscular form.

Labeler Name: Janssen Products, Lp

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Janssen Covid-19 Vaccine Active Ingredient(s)

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

  • JNJ-78436735 50000000000 [PFU]/.5mL

Inactive Ingredient(s)

About 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • ALCOHOL (UNII: 3K9958V90M)
  • HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

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

  • Intramuscular - Administration within a muscle.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Janssen Products, Lp
Labeler Code: 59676
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 01-04-2021 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: 12-31-2022 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’.

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