Glipizide
- Product NDC
- 0591-0845
- Requested package NDC
- 0591-0845-01
- 11-digit product format
- 005910845
- Labeler code
- 0591
- Product ID
- 0591-0845_84db3537-cb18-4bb5-8cd9-05a9da26ec90
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glipizide
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA076467
- Marketing category
- ANDA
- Marketing start
- 2003-11-19
- Marketing end
- 0000-00-00
- Substance
- GLIPIZIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 0591-0845 | 0591-0845-01 | D | Discontinued by firm | 2026-08-17 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0591-0845 | 0591-0845-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0591-0845 | 0591-0845-01 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076467-001 | GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | |
| A076467-002 | GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | |
| A076467-003 | GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076467-001 | AB |
| A076467-002 | AB |
| A076467-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076467-002 | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-11-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076467-003 | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2006-03-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076467-001 | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2003-09-08 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076467-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076467-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076467-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076467-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076467-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076467-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076467-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076467-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076467-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076467-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076467-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076467-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076467-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076467-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076467-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076467-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076467-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076467-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076467-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076467-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076467-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076467-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076467-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076467-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076467-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076467-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076467-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076467-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076467-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076467-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076467-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076467-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076467-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076467-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076467-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076467-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076467-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076467-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076467-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076467-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ec4adfb0-aabc-95b9-ad07-5cb8f8533a09 | Product name | 2 | 20250625 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| b1de1ca9-d9db-4f4b-2103-09e2014d30d5 | Product name | 5 | 20180912 |
| 2dee091b-3b8c-d27a-b1ba-fcb0d32e776a | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0845-01 | EA - Each | 0591-0845 | 040c49e9-d37e-4d9d-96a9-3a4fc33a12f7 | 1 | 2012-07-24 |
| 0591-0845-10 | EA - Each | 0591-0845 | 3c6b6a93-53ba-4594-87bc-850e6e6d790d | 1 | 2012-07-24 |
| 0591-0845-15 | EA - Each | 0591-0845 | e1b49d62-7cbf-4475-aa10-27cd534b26f6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 315107 | glipiZIDE 10 MG 24HR Extended Release Oral Tablet | PSN | 04fad2a9-bbef-4896-9fa0-892e26a6b4c6 | 2 |
| 315107 | 24 HR glipizide 10 MG Extended Release Oral Tablet | SCD | 04fad2a9-bbef-4896-9fa0-892e26a6b4c6 | 2 |
| 315107 | glipizide ER 10 MG 24 HR Extended Release Oral Tablet | SY | 04fad2a9-bbef-4896-9fa0-892e26a6b4c6 | 2 |
| 315107 | glipizide XL 10 MG 24 HR Extended Release Oral Tablet | SY | 04fad2a9-bbef-4896-9fa0-892e26a6b4c6 | 2 |
| 315107 | glipiZIDE 10 MG 24HR Extended Release Oral Tablet | PSN | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 314006 | glipiZIDE 5 MG 24HR Extended Release Oral Tablet | PSN | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 315107 | 24 HR glipizide 10 MG Extended Release Oral Tablet | SCD | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 314006 | 24 HR glipizide 5 MG Extended Release Oral Tablet | SCD | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 315107 | glipizide ER 10 MG 24 HR Extended Release Oral Tablet | SY | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 314006 | glipizide ER 5 MG 24 HR Extended Release Oral Tablet | SY | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 315107 | glipizide XL 10 MG 24 HR Extended Release Oral Tablet | SY | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
| 314006 | glipizide XL 5 MG 24 HR Extended Release Oral Tablet | SY | 6c92a536-508d-4e94-89af-453e3eb2a560 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0591-0845-01 | 00591084501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-0845-01) | 2003-11-19 | 0000-00-00 | No | No | Current |