Research / FdaNdcDirectoryPulse
New FDA Drug Listings Tracker: 2026 statistics from 4,215 public records
The most common approval pathway is OTC monograph: 2,058 of 4,215 records (48.8%) (as of 2026-11-04; source: U.S. FDA National Drug Code (NDC) Directory via openFDA).
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Key findings
- Zalwin's FdaNdcDirectoryPulse dataset holds 4,215 FdaNdcDirectoryPulse records dated 2026-06-28 to 2026-11-03 (as of 2026-11-04; source: U.S. FDA National Drug Code (NDC) Directory via openFDA). #
- The most common approval pathway is OTC monograph: 2,058 of 4,215 records (48.8%) (as of 2026-11-04; source: U.S. FDA National Drug Code (NDC) Directory via openFDA). #
- 596 of 4,215 records (14.1%) are dated within the 30 days before 2026-11-04 (source: U.S. FDA National Drug Code (NDC) Directory via openFDA). #
FdaNdcDirectoryPulse records by approval pathway
| Group | Records | Share |
|---|---|---|
| OTC monograph | 2,058 | 48.8% |
| Generic (ANDA) | 1,270 | 30.1% |
| Other | 438 | 10.4% |
| Brand (NDA) | 145 | 3.4% |
| Biologic (BLA) | 101 | 2.4% |
| Homeopathic | 94 | 2.2% |
| Unapproved (other) | 89 | 2.1% |
| Authorized generic | 20 | 0.5% |
Methodology and data provenance
- Sample: 4,215 public records dated 2026-06-28 to 2026-11-03; illustrative samples excluded.
- Source: U.S. FDA National Drug Code (NDC) Directory via openFDA. Refreshed automatically about every 24 hours; figures above are as of 2026-11-04.
- Shares are of all records in the dataset; totals and medians use only records with a stated amount.
- Organization-level data only. Informational; verify individual records at the official source.
Cite this study
Zalwin Research, "FdaNdcDirectoryPulse statistics" (data as of 2026-11-04), https://zalwin.com/research/fdandcdirectorypulse
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