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| N017783-001 | GLUCOTROL | GLIPIZIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-002 | GLUCOTROL | GLIPIZIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-003 | GLUCOTROL | GLIPIZIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 |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| 2026-08 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 84e616aacf4f… | |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| 2026-08 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | 84e616aacf4f… | |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| 2026-08 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | 84e616aacf4f… | |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 | Advanced Rx of Tennessee, LLC | 213c4e61-9bb7-9d1b-e063-6394a90a7339 | 2024-09-03 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | afb65cc1-a4fb-4771-b09c-dcf6e8c5786e | 2024-08-26 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals, Inc. | 3e295cbc-37c1-4e25-e054-00144ff8d46c | 2024-08-13 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 589dc76d-c347-0589-e053-2991aa0a2520 | 2024-07-18 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 8c27962d-626b-30e6-e053-2a95a90a49c6 | 2024-06-18 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 7c21db4d-6b9b-36c3-e053-2991aa0a0fd9 | 2024-06-12 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 62d569b8-bb34-0e06-e053-2a91aa0a2ae1 | 2024-06-06 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Aphena Pharma Solutions - Tennessee, LLC | f620559f-985b-421f-98df-bc2ca1cb0ece | 2024-02-26 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Actavis Pharma, Inc. | ad55dfd7-ffb5-478a-aa84-1009fa921e22 | 2023-12-31 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 0874340a-75a1-4ac9-b224-80c5c24e1b41 | 2023-12-28 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c | 2023-12-04 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 15308fc4-11e3-4cd5-8f04-ab8e3433cc7d | 2023-12-04 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 4982f018-c53c-48ec-a4e8-4834228bcf2c | 2023-11-24 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 08b01608-73c2-45e0-8de4-c6c401261152 | 2023-10-23 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 695c178f-77f0-451e-b718-72b65e495b7e | 2023-10-18 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | TruPharma LLC | 95ea4c96-84b9-4515-9494-a93d26820f70 | 2023-10-11 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Aphena Pharma Solutions - Tennessee, LLC | 64c2a82f-014c-47d7-b303-23531e6bb723 | 2023-04-14 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NCS HealthCare of KY, LLC dba Vangard Labs | bf5ff427-3ee4-4064-a55e-35daa2f12a06 | 2023-02-27 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Proficient Rx LP | f280acc1-d912-4f2e-b131-440e708c7b1f | 2022-07-01 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Proficient Rx LP | 31618a34-b87b-484c-8b65-1f77d8cd0f28 | 2022-04-01 | 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 |