Application 017783
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 5MG | Yes | No |
| 002 | GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 10MG | Yes | Yes |
| 003 | GLUCOTROL | GLIPIZIDE | TABLET;ORAL | 2.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017783-001 | GLUCOTROL | GLIPIZIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-002 | GLUCOTROL | GLIPIZIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-003 | GLUCOTROL | GLIPIZIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 |
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| 2026-08 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-08 23:34 UTC | 2022-04 | N017783-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N017783-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N017783-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N017783-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N017783-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N017783-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N017783-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N017783-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N017783-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N017783-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017783-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017783-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N017783-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N017783-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N017783-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N017783-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N017783-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N017783-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N017783-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N017783-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N017783-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N017783-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N017783-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N017783-002 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | e593552f-9817-4cb5-b491-31ea57dea4b8 | 2026-02-24 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 9c9a3688-6de9-41db-af82-c4aa9b5b3f92 | 2026-02-20 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | f60b0690-aca9-40ec-956e-bd2ecc35ec54 | 2026-02-16 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 383540fd-2931-49bf-8009-25e8f7fc9bda | 2026-02-10 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | a38cfe61-4aa5-498c-bca5-03a8213303bb | 2026-02-10 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | bde478e6-e290-47e0-9241-ce88d927633e | 2026-02-04 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Preferred Pharmaceuticals Inc. | 410bf280-838d-45af-9b60-15f94ded7581 | 2026-01-28 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | 0ed5ed22-dd53-495d-bc10-0bede4d87926 | 2026-01-19 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Rising Pharma Holdings, Inc. | 0ffe361a-c99b-4f68-a7e2-a67a71c0c496 | 2026-01-17 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | AvPAK | aa1b16bf-e01c-d539-e053-2995a90a2735 | 2026-01-08 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Aurobindo Pharma Limited | 84794a52-b717-488c-8533-6425c83d405f | 2026-01-08 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northstar Rx LLC. | 915636a4-092e-4e2e-9bc0-0d387d996977 | 2026-01-05 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | c16edad6-4271-6ff0-e053-2a95a90a0240 | 2026-01-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | 3bb3b80a-30e8-62fe-e054-00144ff8d46c | 2026-01-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | ab2f4ea6-46e8-268a-e053-2995a90a3977 | 2026-01-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | ff9b3b7a-5ab1-45ec-e053-6294a90af426 | 2026-01-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Proficient Rx LP | f5d7a98c-d1d4-43b9-8d7e-830a33ae0c24 | 2026-01-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | 0a1e1152-ade7-2092-e063-6394a90a99e7 | 2025-12-26 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | 0effd04d-172c-5d8c-e063-6294a90a93f4 | 2025-12-26 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 16fb8bc7-1db1-477e-a201-b3b678b8a84c | 2025-12-03 | Warnings, Adverse reactions | GLIPIZIDE |
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 |
|---|---|---|---|---|---|
| 0049-4110 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4110 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4110 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4120 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4120 | Glucotrol | glipizide | Roerig | NDA | Current |
| 0049-4120 | Glucotrol | glipizide | Roerig | NDA | Current |