Glipizide
- Product NDC
- 53808-0400
- 11-digit product format
- 538080400
- Labeler code
- 53808
- Product ID
- 53808-0400_909faecb-fb9e-48a7-a66b-0ae151d1e9a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLIPIZIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA075795
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- GLIPIZIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53808-0400 | I | Inactivated by FDA | 2026-08-07 | ||
| excluded package | package | 53808-0400 | 53808-0400-1 | I | Inactivated by FDA | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53808-0400-1 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 53808-0400-1 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075795-001 | GLIPIZIDE | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | |
| A075795-002 | GLIPIZIDE | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075795-001 | AB |
| A075795-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | RS | 2001-06-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2001-06-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2001-06-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2001-06-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2001-06-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075795-001 | GLIPIZIDE | 5MG | TABLET / ORAL | AB | 2001-06-13 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A075795-002 | GLIPIZIDE | 10MG | TABLET / ORAL | AB | 2001-06-13 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075795-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075795-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075795-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075795-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075795-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075795-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075795-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075795-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075795-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075795-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075795-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075795-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075795-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075795-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075795-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075795-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075795-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075795-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075795-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075795-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075795-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075795-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075795-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075795-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075795-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075795-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075795-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075795-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075795-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075795-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075795-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075795-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075795-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075795-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075795-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075795-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A075795-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A075795-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A075795-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A075795-002 | AB | 1 | 782e0a99824c… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ec4adfb0-aabc-95b9-ad07-5cb8f8533a09 | Product name | 2 | 20250625 |
| b1de1ca9-d9db-4f4b-2103-09e2014d30d5 | Product name | 5 | 20180912 |
| 2dee091b-3b8c-d27a-b1ba-fcb0d32e776a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0400-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0087-f424-e053-dadaa90a57ce | Glipizide Tablet USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0400-1 | Glipizide | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLIPIZIDE | ACTIVE INGREDIENT | X7WDT95N5C | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| GLIPIZIDE | ACTIVE MOIETY | X7WDT95N5C | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0400 | GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100804_e9f904fa-5709-48df-a4cd-4604b656b1a1.zip |
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. | 376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb4 | 2026-06-29 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | REMEDYREPACK INC. | 212897cb-7de7-4711-aaf4-44234f950e9f | 2026-06-26 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | American Health Packaging | ff6805bb-b5f0-46d3-bf1d-3333b63ff1ae | 2026-06-24 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Coupler LLC | 53e650f1-f755-e3ad-e063-6294a90ae309 | 2026-06-10 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Coupler LLC | 51b35391-7672-c02f-e063-6294a90af54e | 2026-05-13 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Cardinal Health 107, LLC | bf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a | 2026-05-08 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Preferred Pharmaceuticals, Inc. | 097424ef-612f-4bc2-809a-e5bb8eeae244 | 2026-05-06 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Major Pharmaceuticals | d3b5677c-2265-47c8-beeb-bf12106056ba | 2026-03-13 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Legacy Pharmaceutical Packaging, LLC | 116ffc6a-735c-49e0-a9d5-69b6bc3e3706 | 2026-03-03 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 9c9a3688-6de9-41db-af82-c4aa9b5b3f92 | 2026-02-20 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | f60b0690-aca9-40ec-956e-bd2ecc35ec54 | 2026-02-16 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 383540fd-2931-49bf-8009-25e8f7fc9bda | 2026-02-10 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | a38cfe61-4aa5-498c-bca5-03a8213303bb | 2026-02-10 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | 0ed5ed22-dd53-495d-bc10-0bede4d87926 | 2026-01-19 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | NuCare Pharmaceuticals,Inc. | 6282c653-9e9c-6810-e053-2991aa0a4a8e | 2026-01-13 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | AvPAK | aa1b16bf-e01c-d539-e053-2995a90a2735 | 2026-01-08 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Northwind Health Company, LLC | c16edad6-4271-6ff0-e053-2a95a90a0240 | 2026-01-01 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | A-S Medication Solutions | 16fb8bc7-1db1-477e-a201-b3b678b8a84c | 2025-12-03 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | PD-Rx Pharmaceuticals, Inc. | 1b2e5656-9da9-4fab-bf01-ed75896b836a | 2025-07-17 | Warnings, Adverse reactions | 075795 ANDA075795 |
| Glipizide | GLIPIZIDE | Apotex Corp. | dcf426b8-bcdc-8214-a1b6-6388bd3399a0 | 2025-07-01 | Warnings, Adverse reactions | 075795 ANDA075795 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310490 | glipiZIDE 5 MG Oral Tablet | PSN | e9f904fa-5709-48df-a4cd-4604b656b1a1 | 1 |
| 310490 | glipizide 5 MG Oral Tablet | SCD | e9f904fa-5709-48df-a4cd-4604b656b1a1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0400-1 | 53808040001 | 30 in 1 BLISTER PACK | Historical |