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| N017783-001 | GLUCOTROL | GLIPIZIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-002 | GLUCOTROL | GLIPIZIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-003 | GLUCOTROL | GLIPIZIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 |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| 2026-08 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 84e616aacf4f… | |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| 2026-08 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 84e616aacf4f… | |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| 2026-08 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 84e616aacf4f… | |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 | A-S Medication Solutions | 3b111484-78ef-4db9-95ee-6cc4b6acdd59 | 2025-11-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 155216cf-4bad-479a-83b6-032d4bd11c2e | 2025-11-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | c829b7bf-1a12-44b2-b5ce-fd44a1f0d333 | 2025-10-20 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Proficient Rx LP | d5398166-5698-4ee5-bd41-3c24e4445b53 | 2025-10-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Advanced Rx of Tennessee, LLC | 3d87cc75-7a0d-46a2-e063-6294a90a6d49 | 2025-08-29 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Preferred Pharmaceuticals Inc. | 4d490a3a-abdc-4ff4-83fb-f302f51e3023 | 2025-08-29 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 5c627a52-e4ca-7103-e053-2a91aa0ae13f | 2025-08-08 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | 1b2e5656-9da9-4fab-bf01-ed75896b836a | 2025-07-17 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | American Health Packaging | aaf029d3-027e-4ae8-8ec5-3a4c16f9bd28 | 2025-04-24 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | b31ab6dd-0277-43ee-a054-f20c462f0c56 | 2025-04-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 0b29837b-c39b-16d2-e063-6394a90abe61 | 2025-02-03 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Proficient Rx LP | 6427db20-6783-439f-8c2d-64d1a6fcb9fc | 2025-02-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 86e6583c-b290-e2b5-e053-2991aa0ab485 | 2025-01-31 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 0338aff9-29f9-405e-b516-06ef4b863863 | 2024-12-20 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | de67216c-4579-434e-b388-5e9b104f127a | 2024-10-25 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 8948b81f-401c-478e-bb3d-3b0368f5ed8b | 2024-10-25 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 4995328f-287c-4d4a-9b5f-9d354cc530fb | 2024-10-08 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | abab5b07-08eb-4416-ae03-3656a078caa2 | 2024-10-07 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | be20727f-2724-457a-89ac-aa96604a0015 | 2024-10-04 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 560448dd-3690-43d9-9667-925f20bb816e | 2024-10-04 | 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 |