FDA NDC Directory
Recently listed NDCs
Finished products in the FDA NDC Directory with the newest marketing start dates — new brands and generics, and new strengths or packages of existing products.
A listing is not an approval
The date shown is the marketing start date the labeler reported. Many new listings are generics, repackaged or relabeled products, or new package sizes. The marketing category (NDA, ANDA, BLA) on each product page says under what authority it is marketed.
Newest first
8 listings in the last 90 days
| Product | Strength | Form · route | Labeler | Listed | Product NDC |
|---|---|---|---|---|---|
| Comirnatycovid-19 vaccine, mrna | Bnt-162b2 omicron (Xfg) mrna .0158 mg/.48mL | Injection, SuspensionIntramuscular | Pfizer Laboratories Div Pfizer Inc | Aug 27, 2026 | 0069-2609 |
| Comirnatycovid-19 vaccine, mrna | Bnt-162b2 omicron (Xfg) mrna .042 mg/.418mL | Injection, SuspensionIntramuscular | Pfizer Laboratories Div Pfizer Inc | Aug 27, 2026 | 0069-2631 |
| Nuvaxovid 2026-27nvx-cov2928 | Nvx-cov2928 5 ug/.5mL | Injection, SuspensionIntramuscular | Sanofi Vaccines US Inc. | Aug 27, 2026 | 49281-026 |
| Spikevaxcovid-19 vaccine, mrna | Cx-055611 50 ug/.5mL | Injection, SuspensionIntramuscular | Moderna US, Inc. | Aug 17, 2026 | 80777-114 |
| Spikevaxcovid-19 vaccine, mrna | Cx-055611 25 ug/.25mL | Injection, SuspensionIntramuscular | Moderna US, Inc. | Aug 17, 2026 | 80777-115 |
| mNEXSPIKEcovid-19 vaccine, mrna | Cx-055610 10 ug/.2mL | Injection, SuspensionIntramuscular | Moderna US, Inc. | Aug 17, 2026 | 80777-401 |
| mFLUSIVAinfluenza vaccine, mrna | RNA-101-bfl3 12.5 ug/.38mL + 2 more ingredients | Injection, SuspensionIntramuscular | Moderna US, Inc. | Aug 5, 2026 | 80777-500 |
| Flucelvaxinfluenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/victoria/800/2024 cvr-289 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated) | Influenza a virus a/georgia/12/2022 cvr-167 (H1n1) antigen (Mdck cell derived, Propiolactone inactivated) 15 ug/.5mL + 2 more ingredients | Injection, SuspensionIntramuscular | Bamboo US BidCo LLC | Aug 1, 2026 | 83703-088 |