Glyburide
- Product NDC
- 50090-0494
- 11-digit product format
- 500900494
- Labeler code
- 50090
- Product ID
- 50090-0494_269f24ab-8889-4221-b968-14e228b403e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074388
- Marketing category
- ANDA
- Marketing start
- 1995-08-30
- 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 product | product | 50090-0494 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 50090-0494 | 50090-0494-0 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50090-0494 | 50090-0494-2 | I | Inactivated by FDA | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-0494-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-0494-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-0494-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-0494-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-0494-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50090-0494-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-0494-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50090-0494-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-0494-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50090-0494-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-0494-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50090-0494-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-0494-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50090-0494-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-0494-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50090-0494-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-0494-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50090-0494-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-0494-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50090-0494-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-0494-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50090-0494-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-0494-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50090-0494-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-0494-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50090-0494-2 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-0494-0 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50090-0494-2 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-0494-0 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50090-0494-2 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074388-001 | GLYBURIDE | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | |
| A074388-002 | GLYBURIDE | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | |
| A074388-003 | GLYBURIDE | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074388-001 | AB1 |
| A074388-002 | AB1 |
| A074388-003 | 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 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074388-002 | GLYBURIDE | 2.5MG | TABLET / ORAL | AB1 | 1995-08-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074388-003 | GLYBURIDE | 5MG | TABLET / ORAL | AB1 | RS | 1995-08-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074388-001 | GLYBURIDE | 1.25MG | TABLET / ORAL | AB1 | 1995-08-29 | 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 | A074388-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074388-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074388-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074388-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074388-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074388-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074388-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074388-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074388-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074388-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074388-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074388-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074388-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074388-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074388-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074388-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074388-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074388-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074388-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074388-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074388-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074388-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074388-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074388-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074388-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074388-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074388-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074388-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074388-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074388-003 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074388-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074388-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074388-003 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074388-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074388-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074388-003 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074388-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074388-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074388-003 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074388-001 | AB1 | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bea938a6-c880-985b-d27b-b59b0d8b5a77 | Product name | 3 | 20170626 |
| 0600b0d3-c32a-40bb-8d87-3a2934cd8f2f | Product name | 1 | 20170616 |
| 64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6 | Product name | 2 | 20160609 |
| 5a2baaae-1290-c05e-207f-b1367e9eb46a | Product name | 2 | 20151005 |
| b044018d-bcdc-e68d-63da-1ad6886aea64 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-0494-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f7f7-0266-e053-dadaa90a7c1a | GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only |
| 50090-0494-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-f7f7-0266-e053-dadaa90a7c1a | GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0494-0 | Glyburide | 30 in 1 BOTTLE | TABLET | 30 | 11 | |
| 50090-0494-2 | Glyburide | 200 in 1 BOTTLE | TABLET | 200 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0494-0 | EA - Each | 50090-0494 | f974e6ab-ad46-4684-8789-cffef83e60a8 | 1 | 2018-09-05 |
| 50090-0494-2 | EA - Each | 50090-0494 | d40d2af3-5e5d-4b43-8303-add1c6b5ef72 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0494 | GLYBURIDE TABLET [A-S MEDICATION SOLUTIONS] | 11 | Legacy NDC, 2 package rows | 20210211_64a1ee72-cbe4-4558-899c-825c4b6d9435.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 |
|---|---|---|---|---|---|---|
| Glyburide | GLYBURIDE | Preferred Pharmaceuticals Inc. | bc8df889-25e0-49a0-bbec-a3dfae8bbb8a | 2026-01-27 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | Coupler LLC | 4573af7f-3c71-e323-e063-6394a90aa9eb | 2025-12-08 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | Proficient Rx LP | 6f65131c-90df-45ab-95fb-c36f411c6fbe | 2025-07-01 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals, Inc. | 25516c2a-f1b5-9ee4-e063-6394a90ab46b | 2024-10-25 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | NuCare Pharmaceuticals, Inc. | 21786ac0-da3c-16cb-e063-6394a90a4596 | 2024-09-06 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | A-S Medication Solutions | 922d1080-52c6-41e4-a310-533d8ca18594 | 2023-08-28 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | Proficient Rx LP | ec45f0d8-cab8-4822-895b-17bb443a4f98 | 2019-11-01 | Warnings, Adverse reactions | 074388 ANDA074388 |
| Glyburide | GLYBURIDE | Teva Pharmaceuticals USA, Inc. | a56f100f-0f42-4188-81ab-04644b824040 | 2015-05-31 | Warnings, Adverse reactions | 074388 ANDA074388 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310534 | glyBURIDE 2.5 MG Oral Tablet | PSN | 64a1ee72-cbe4-4558-899c-825c4b6d9435 | 11 |
| 310534 | glyburide 2.5 MG Oral Tablet | SCD | 64a1ee72-cbe4-4558-899c-825c4b6d9435 | 11 |
| 310534 | glibenclamide 2.5 MG Oral Tablet | SY | 64a1ee72-cbe4-4558-899c-825c4b6d9435 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-0494-0 | 50090049400 | 30 TABLET in 1 BOTTLE (50090-0494-0) | 30 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |
| 50090-0494-2 | 50090049402 | 200 TABLET in 1 BOTTLE (50090-0494-2) | 200 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |