Glyburide
- Product NDC
- 66267-102
- Requested package NDC
- 66267-102-60
- 11-digit product format
- 662670102
- Labeler code
- 66267
- Product ID
- 66267-102_b8a71017-8702-1b3f-e053-2995a90a2414
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090937
- Marketing category
- ANDA
- Marketing start
- 2010-10-05
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE
- Active strength
- 3 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 | 66267-102 | 66267-102-60 | D | Discontinued by firm | 2026-08-03 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090937-001 | GLYBURIDE | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | |
| A090937-002 | GLYBURIDE | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | |
| A090937-003 | GLYBURIDE | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090937-001 | AB1 |
| A090937-002 | AB1 |
| A090937-003 | AB1 |
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 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090937-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 2011-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090937-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | 2011-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090937-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 2011-02-28 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A090937-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090937-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090937-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090937-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090937-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090937-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090937-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090937-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090937-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090937-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090937-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090937-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090937-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090937-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090937-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090937-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090937-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090937-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090937-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090937-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090937-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090937-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090937-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090937-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090937-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090937-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090937-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090937-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090937-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090937-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090937-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090937-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090937-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090937-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090937-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090937-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090937-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090937-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090937-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090937-001 | AB1 | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| GLYBURIDE | GLYBURIDE | Bryant Ranch Prepack | 9cdd30e7-512a-4f00-a4de-0a154d143ce9 | 2026-05-18 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | Northwind Health Company, LLC | d9cb9251-7b31-72a0-e053-2a95a90a4315 | 2026-01-01 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | Northwind Health Company, LLC | db47a517-f8bb-136f-e053-2a95a90ad8c5 | 2026-01-01 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | Chartwell RX, LLC | 7e661288-2d24-4403-86a1-754afa1d04ff | 2025-12-09 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 33418bba-c5ea-4c0f-9d28-31dc2724c6c3 | 2025-10-31 | Adverse reactions | 090937 ANDA090937 |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals,Inc. | 7ee41cd3-461f-3408-e053-2991aa0a863d | 2025-02-06 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | Bryant Ranch Prepack | 05341afe-5b7a-462a-a196-689cb09f83fc | 2025-01-28 | Adverse reactions | 090937 ANDA090937 |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals, Inc. | 3e354b4d-70e4-5089-e054-00144ff88e88 | 2024-08-13 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | NuCare Pharmaceuticals,Inc. | a12342fb-123c-2951-e053-2a95a90ac596 | 2024-06-20 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | NuCare Pharmaceuticals,Inc. | a1233548-bbb8-34aa-e053-2a95a90aea53 | 2024-06-20 | Adverse reactions | 090937 ANDA090937 |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals,Inc. | 901c50d5-31e7-b073-e053-2995a90abfeb | 2024-06-19 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | A-S Medication Solutions | 7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd | 2023-12-03 | Adverse reactions | 090937 ANDA090937 |
| GLYBURIDE | GLYBURIDE | A-S Medication Solutions | 3c91a408-973b-4572-832f-515f61d5be1f | 2023-02-04 | Adverse reactions | 090937 ANDA090937 |
| Glyburide | GLYBURIDE | Proficient Rx LP | b292cb9b-7348-4c07-a871-bc091229fdf8 | 2019-11-01 | Adverse reactions | 090937 ANDA090937 |
| Glyburide | GLYBURIDE | Proficient Rx LP | 240c3ac6-9aab-4185-994e-a0254e3aeb61 | 2019-11-01 | Adverse reactions | 090937 ANDA090937 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66267-102-60 | 66267010260 | 60 TABLET in 1 BOTTLE (66267-102-60) | 60 tablet | 2016-10-06 | 0000-00-00 | No | No | Current |