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| N017783-001 | GLUCOTROL | GLIPIZIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-002 | GLUCOTROL | GLIPIZIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | |
| N017783-003 | GLUCOTROL | GLIPIZIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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| 2026-07 | N017783-001 | GLUCOTROL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | caaa826d4ba7… | |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| 2026-07 | N017783-002 | GLUCOTROL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1984-05-08 | caaa826d4ba7… | |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| 2026-07 | N017783-003 | GLUCOTROL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-05-11 | caaa826d4ba7… | |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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… |
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. | e4831ddb-9680-40cb-a060-4ba77c52d0aa | 2026-08-14 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 03151cb5-d32b-4484-8f2a-8c5d24c7f6f1 | 2026-08-05 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | d9b6464f-6fe6-446e-8150-d0c15c46fee8 | 2026-07-31 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | 3de8b0a7-b848-40af-8406-fe6924ff41db | 2026-07-31 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Preferred Pharmaceuticals Inc. | e0de2d19-b24b-46af-a10e-0b78c51350a4 | 2026-07-31 | Warnings, Adverse reactions | GLIPIZIDE |
| Glucotrol XL | GLIPIZIDE | Roerig | eed99b60-d043-4249-9b2a-f05e46fb588d | 2026-07-21 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | ANI Pharmaceuticals, Inc. | 252ba4e0-8dc3-43e3-be00-32570dc095bd | 2026-07-13 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | c2aadc88-22d2-467c-b2cb-03efb5a1f1c1 | 2026-07-02 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4 | 2026-06-29 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 212897cb-7de7-4711-aaf4-44234f950e9f | 2026-06-26 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | American Health Packaging | ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae | 2026-06-24 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | St. Mary's Medical Park Pharmacy | 1b2ef6e2-5e7c-761e-e063-6294a90addd0 | 2026-06-22 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals, Inc. | 4c4dfe64-d1c5-65ec-e063-6394a90aead5 | 2026-06-19 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 06fb6c56-5609-41d9-8389-eba81432218d | 2026-06-11 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 5ca7e38b-84cb-4043-b97e-e2f5cd82b442 | 2026-06-11 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Coupler LLC | 53e650f1-f755-e3ad-e063-6294a90ae309 | 2026-06-10 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 0df8f606-97b3-463c-a132-338cf4630a71 | 2026-06-10 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | c8cfd137-7b41-460f-a463-141c9d1985ff | 2026-06-04 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | St. Mary's Medical Park Pharmacy | 0ccc17ca-fff8-0449-e063-6294a90af36d | 2026-06-03 | Warnings, Adverse reactions | GLIPIZIDE |
| Glipizide | GLIPIZIDE | Bryant Ranch Prepack | 9b405ff3-6ce5-460a-9406-db92e0e6ab1b | 2026-05-21 | Warnings, Adverse reactions | GLIPIZIDE |
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 |