METFORMIN HYDROCHLORIDE | A090564 | GRANULES INDIA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-7602 Senores Pharmaceuticals, Inc filed a suitability petition requesting that the FDA determine whether a specific drug substance or excipient is suitable for use in pharmaceutical products. The petition seeks FDA guidance on the regulatory acceptability and specifications for the substance to support t | Suitability | 2026-07-08 | Open | Senores Pharmaceuticals, Inc |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5991 Hyman, Phelps & McNamara, P.C. filed this suitability petition to request FDA determination regarding whether a drug substance or excipient is suitable for use in pharmaceutical products, though the specific drug or product name is not identified in this document excerpt. | Suitability | 2026-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6625 The law firm Hyman, Phelps & McNamara, P.C., filed a suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Metformin Hydrochloride Tablets at 375 mg strength suitable for submission in an Abbreviated New | Suitability | 2025-12-03 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Harman Finochem Limited FDA-2019-P-3877 Harman Finochem Limited filed this citizen petition requesting that the FDA Commissioner confirm that Glucophage (metformin hydrochloride tablets), NDA 020357 held by Bristol Myers Squibb, was not withdrawn from sale for safety or effectiveness reasons, as required under 21 CFR 314.161 and 21 CFR 31 | 505(q) | 2019-08-20 | Granted | Harman Finochem Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0244
per ea
Lowest NADAC/Unit
$0.0148
per ea
Brand NDCs
0
Generic NDCs
29
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70010006409METFORMIN HCL 850 MG TABLET | $0.0244 | EA | Generic | — | 2026-10-21 |
| 70010006499METFORMIN HCL 850 MG TABLET | $0.0244 | EA | Generic | — | 2026-10-21 |
| 00904716361METFORMIN HCL 850 MG TABLET | $0.0244 | EA | Generic | — | 2026-10-21 |
| 68645058359METFORMIN HCL 850 MG TABLET | $0.0244 | EA | Generic | — | 2026-10-21 |
| 67877056210METFORMIN HCL 850 MG TABLET | $0.0244 | EA | Generic | — | 2026-10-21 |
| 67877056205METFORMIN HCL 850 MG TABLET | $0.0244 | EA | Generic | — | 2026-10-21 |
Showing 6 of 29 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.