LACTULOSE | A074712 | CUMBERLAND PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-4150 · 14 docket documents The law firm Hyman, Phelps & McNamara submitted a suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Lactulose for Oral Solution, 15 g/Packet, suitable for submission as an AN | Suitability | 2025-09-23 | Open | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.95
per ea
Lowest NADAC/Unit
$7.91
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 66220072930KRISTALOSE 20 GM PACKET | $9.95 | EA | — | $7.98 | 2026-06-17 |
| 66220071930KRISTALOSE 10 GM PACKET | $9.59 | EA | — | $7.91 | 2026-06-17 |
| 85592082930LACTULOSE 20 GM PACKET | $7.98 | EA | Generic | — | 2026-06-17 |
| 85592081930LACTULOSE 10 GM PACKET | $7.91 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.