NICOTINE | A074612 | DIFGEN PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & Mcnamara, PC FDA-2013-P-1640 · 4 docket documents Hyman, Phelps & McNamara, PC filed this citizen petition on December 5, 2013 under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA require sponsors of over-the-counter transdermal nicotine patches approved under NDAs pursuant to Section 505(b) or ANDAs pursuant to Section | 505(q) | 2013-12-12 | Partially Denied | Hyman, Phelps & Mcnamara, PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.77
per ea
Lowest NADAC/Unit
$1.74
per ea
Brand NDCs
0
Generic NDCs
27
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68001043491NICOTINE 21 MG/24HR PATCH | $1.77 | EA | Generic | — | 2026-06-17 |
| 00536589653NICOTINE 21 MG/24HR PATCH | $1.77 | EA | Generic | — | 2026-06-17 |
| 00536589671NICOTINE 21 MG/24HR PATCH | $1.77 | EA | Generic | — | 2026-06-17 |
| 00536589688NICOTINE 21 MG/24HR PATCH | $1.77 | EA | Generic | — | 2026-06-17 |
| 70000051201NICOTINE 21 MG/24HR PATCH | $1.77 | EA | Generic | — | 2026-06-17 |
| 70000051202NICOTINE 21 MG/24HR PATCH | $1.77 | EA | Generic | — | 2026-06-17 |
Showing 6 of 27 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.