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FDA-CBER-2021-5683-1150219
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
w ww.fda.gov
Our STN: BL 125742/0 UNIQUE INGREDIENT IDENTIFIER
(UNII) CODE ASSIGNMENT
August 6, 2021
BioNTech Manufacturing GmbH
Attention: Elisa Harkins
Pfizer Inc.
500 Arcola Road
Collegeville , PA 19426
Dear Ms. Harkins :
The Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85)
(FDAAA) requires that establishment registration and drug listing be accomplished
electronically. To facilitate your electronic establishment registration and drug listing
process, we have assigned Unique Ingredient Identifier (UNII) codes for your product ,
COVID -19 Vaccine, mRNA .
Active Ingredient/Active Moiety/ Basis of Strength: UNII:
BNT162b2 drug substance 5085ZFP6SJ
Excipients : UNII:
ALC-0159 PJH39UMU6H
ALC-0315 AVX8DX713V
POTASSIUM CHLORIDE 660YQ98I10
MONOBASIC POTASSIUM PHOSPHATE 4J9FJ0HL51
SODIUM CHLORIDE 451W47IQ8X
SODIUM PHO SPHATE, DIBASIC, UNSPECIFIED FORM GR686LBA74
SUCROSE C151H8M554
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE 043IPI2M0K
CHOLESTEROL 97C5T2UQ7J
WATER 059QF0KO0R
Please be aware that your UNII codes and substance name have been published on
our Structured Product Labeling Resources website at https://www.fda.gov/industry/fda-
resources -data-standards/structured-product -labeling-resources . If you need to contact
us, please refer to BL 125742/0.
UNI
I codes are a part of the joint United States Pharmacopeia (USP)/FDA Substance
Registration System (SRS), which has been designed to support healt h information
technology initiatives by providing unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information.
FDA-CBER-2021-5683-1150220
Page 2 – STN BL 125742/0 – Elisa Harkins
These names and identifiers are accessible through the USP website at
http://www.usp.org and U SP publications, the Data Standards Council website at
https://www.fda.gov/indus try/fda -resources -data-standards/fda-data-standards -council
and the NCI Thesaurus website at http://evs.nci.nih.gov .
If you have any questions, please contact me at 301-796-2640 or
[email protected] .
Sincerely ,
CAPT Mike Smith, Ph.D.
Regulatory Project Manager
Division of Vaccines and
Related Product Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
FDA-CBER-2021-5683-1150221