NDC 0310-1222 Astrazeneca Covid-19 Vaccine

Azd1222

NDC Product Code 0310-1222

NDC 0310-1222-15

Package Description: 10 VIAL, MULTI-DOSE in 1 CARTON > 5 mL in 1 VIAL, MULTI-DOSE (0310-1222-10)

NDC Product Information

Astrazeneca Covid-19 Vaccine with NDC 0310-1222 is a a vaccine lable product labeled by Astrazeneca Pharmaceuticals Lp. The generic name of Astrazeneca Covid-19 Vaccine is azd1222. The product's dosage form is injection, suspension and is administered via intramuscular form.

Labeler Name: Astrazeneca Pharmaceuticals Lp

Dosage Form: Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.

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.

Astrazeneca 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.

  • AZD-1222 50000000000 {VP}/.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.

  • HISTIDINE (UNII: 4QD397987E)
  • HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • ALCOHOL (UNII: 3K9958V90M)
  • SUCROSE (UNII: C151H8M554)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • 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: Astrazeneca Pharmaceuticals Lp
Labeler Code: 0310
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: 12-22-2020 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: 12-31-2021 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’.

* Please review the disclaimer below.

Astrazeneca Covid-19 Vaccine Product Label Images

Astrazeneca Covid-19 Vaccine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Package/Label Display Panel – Vial Label

AstraZeneca COVID-19 Vaccine                         NDC 0310-1222-10For use under Emergency Use AuthorizationSuspension for Intramuscular InjectionAfter first use, discard after:6 hours at 20°-25°C (68°-77°F), or48 hours at 2°-8°C (36°-46°F)For Exp Date: seewww.azcovid-19.comMulti-dose vial (10 doses of 0.5 mL)

Package/Label Display Panel – Vial Carton

NDC 0310-1222-15AstraZeneca COVID-19 VaccineFor use under Emergency Use AuthorizationSuspension for Intramuscular InjectionStore at 2°-8°C (36°-46°F) in original carton to protect from light.Do not freeze or shake. No preservative.Discard 6 hours after first use when held at 20°-25°C (68°-77°F).Discard 48 hours after first use when held at 2°-8°C (36°-46°F).10 Multi-dose vials(each vial contains 10 doses of 0.5 mL)AstraZeneca

* Please review the disclaimer below.