Application 020357
- Type
- NDA
- Sponsor
- EMD SERONO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | TABLET;ORAL | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020357-001 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | |
| N020357-002 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | |
| N020357-003 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | |
| N020357-004 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | |
| N020357-005 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020357-001 | GLUCOPHAGE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020357-002 | GLUCOPHAGE | 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1995-03-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020357-003 | GLUCOPHAGE | 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020357-004 | GLUCOPHAGE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020357-005 | GLUCOPHAGE | 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-11-05 | 5bbf6a4d5a75… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 41408f64-d366-403e-9595-464ab25c6f97 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 68d0b1a6-c99e-42cf-afdf-b71ee73c4424 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9171d369-d35a-40e4-a9ad-26484e66fc5e | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 30658e19-8e6e-49aa-a007-e414224797c5 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 1503bbe4-0ac5-479b-9900-d38e49236bf0 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | e22a8545-86a6-439e-a758-29c4d6ed8bfe | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Cardinal Health 107, LLC | 46cb7e3f-c739-433d-9dbe-427c2d95bef1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Chartwell RX, LLC | 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 13235d8e-ac3a-45b4-9c5d-9a9012951dfe | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | 5aa1c86c-f2c8-49b1-8f81-47b11386c5d3 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | 4ac6d01a-af26-44e7-ae2e-3618de0080aa | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | REMEDYREPACK INC. | d5228e81-9c86-4781-b984-20feaa2ae779 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5647230e-5bc6-1802-e063-6394a90a2724 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Aurobindo Pharma Limited | fc466c46-abaa-4675-aef2-4b1a1adfd912 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 14f3091c-f243-4364-b433-727c7d4ef8d5 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 17050df5-9e95-4e1b-ac75-34add289b139 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE ER | METFORMIN HYDROCHLORIDE | Leading Pharma, LLC | 3dca884d-ec44-496f-9eeb-31fd8fa3f574 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Ascend Laboratories, LLC | a944a167-e3ac-4084-af1c-22b48713471c | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 9eebed09-2562-4d21-b3b3-c06562fe3f99 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | MARKSANS PHARMA LIMITED | d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0087-6060 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6060 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6070 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6070 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6071 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6071 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 55289-211 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54395 | SUPPL | 2018-05-31 |
| 54381 | SUPPL | 2018-05-31 |
| 47948 | SUPPL | 2017-04-12 |
| 47947 | SUPPL | 2017-04-12 |
| 47934 | SUPPL | 2017-04-11 |
| 47933 | SUPPL | 2017-04-11 |
| 34537 | SUPPL | 2008-08-29 |
| 2371 | SUPPL | 2008-08-28 |
| 41293 | SUPPL | 2007-04-11 |
| 34536 | SUPPL | 2006-11-06 |
| 24817 | SUPPL | 2006-11-06 |
| 24816 | SUPPL | 2004-03-24 |
| 2370 | SUPPL | 2004-03-24 |
| 24815 | SUPPL | 2002-01-08 |
| 24814 | SUPPL | 2001-04-23 |
| 41292 | SUPPL | 2000-12-15 |
| 2369 | SUPPL | 2000-12-15 |
| 34535 | SUPPL | 2000-02-15 |
| 20604 | SUPPL | 1999-09-22 |
| 41291 | SUPPL | 1998-10-22 |
| 2368 | SUPPL | 1998-10-22 |
| 41290 | SUPPL | 1997-11-06 |
| 57421 | ORIG | 1994-07-13 |