Application 021202
- Type
- NDA
- Sponsor
- EMD SERONO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N021202-001 | GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | |
| N021202-004 | GLUCOPHAGE XR | METFORMIN HYDROCHLORIDE | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021202-001 | GLUCOPHAGE XR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021202-004 | GLUCOPHAGE XR | 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021202-001 | GLUCOPHAGE XR | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021202-004 | GLUCOPHAGE XR | 750MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021202-001 | GLUCOPHAGE XR | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021202-004 | GLUCOPHAGE XR | 750MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021202-001 | GLUCOPHAGE XR | 500MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2000-10-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021202-004 | GLUCOPHAGE XR | 750MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 2003-04-11 | 74a2ff9319b5… |
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 | NuCare Pharmaceuticals,Inc. | 0865f83f-0f34-0690-e063-6294a90abf04 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0b3d5420-d60c-8385-e063-6394a90abb6c | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | Proficient Rx LP | f1530d4f-21d9-4a4f-a814-07b180828ecd | 2025-02-01 | Warnings | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Proficient Rx LP | 7cb47c3e-6657-4c11-8aa2-ae172e5a8529 | 2025-02-01 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Lifsa Drugs, LLC | a2385bcd-0943-4411-8658-c22b50360385 | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | RedPharm Drug, Inc. | fc61bafa-a506-14ae-e053-6394a90a9c7d | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE EXTENDED RELEASE | METFORMIN HYDROCHLORIDE | direct rx | a84cf1a3-3820-cd1b-e053-2995a90acf45 | 2025-01-22 | Warnings | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4adeddf2-f449-4a61-9658-dfbff7c50230 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride ER | METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 27d6fdbc-27a8-c599-e063-6394a90a2233 | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 0f251f2c-97f3-4048-84f2-81fea03685aa | 2025-01-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride Oral Solution | METFORMIN HYDROCHLORIDE | TRUPHARMA, LLC | 73691c6c-8841-4c5d-b4a5-c3ed3b5effa1 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride Oral Solution | METFORMIN HYDROCHLORIDE | Saptalis Pharmaceuticals, LLC. | df61d56e-18ff-404c-b671-42b39aa23574 | 2024-12-23 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | 286d959a-51cb-4dbd-a3e8-1ea2f00b54c7 | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 289dc8ec-42c8-1d09-e063-6394a90a97f0 | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Zydus Lifesciences Limited | 5043d03e-3c9d-4c96-b48d-187f02a1d27c | 2024-12-05 | METFORMIN HYDROCHLORIDE | |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 565610b8-a9a0-4e5e-866d-81d9501a817d | 2024-11-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 2d2ebf52-3d5e-4fad-b7f7-c9280957574c | 2024-11-15 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin hydrochloride | METFORMIN HYDROCHLORIDE | Oceanside Pharmaceuticals | 74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7 | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | c2bbaa0c-5b05-4335-882f-14f1b443edd7 | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
| Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | A-S Medication Solutions | 54ca16e6-1213-4877-8ace-477c764c8e76 | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | METFORMIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0087-6063 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6063 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6064 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
| 0087-6064 | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | Bristol-Myers Squibb Company | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54396 | SUPPL | 2018-05-31 |
| 54382 | SUPPL | 2018-05-31 |
| 47946 | SUPPL | 2017-04-12 |
| 47945 | SUPPL | 2017-04-12 |
| 47936 | SUPPL | 2017-04-11 |
| 47935 | SUPPL | 2017-04-11 |
| 14628 | SUPPL | 2008-08-29 |
| 27051 | SUPPL | 2008-08-28 |
| 36336 | SUPPL | 2006-11-06 |
| 4628 | SUPPL | 2006-11-06 |
| 42018 | ORIG | 2004-06-04 |
| 4627 | SUPPL | 2004-03-24 |
| 4626 | SUPPL | 2004-03-24 |
| 4625 | SUPPL | 2003-04-18 |
| 14627 | SUPPL | 2003-04-17 |
| 4624 | SUPPL | 2002-01-08 |
| 4623 | SUPPL | 2001-04-19 |
| 14626 | ORIG | 2000-10-13 |
| 4622 | ORIG | 2000-10-13 |