Glimepiride
- Product NDC
- 70518-2412
- 11-digit product format
- 705182412
- Labeler code
- 70518
- Product ID
- 70518-2412_e81805fb-a2d3-9392-e053-2a95a90a55f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2019-11-10
- Marketing end
- 0000-00-00
- Substance
- GLIMEPIRIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-2412 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-2412 | 70518-2412-0 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-2412 | 70518-2412-1 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 70518-2412 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2412 | 70518-2412-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2412 | 70518-2412-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | 70518-2412 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | ||
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-2412 | 70518-2412-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-2412 | 70518-2412-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 70518-2412 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2412 | 70518-2412-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2412 | 70518-2412-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078181-001 | GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | |
| A078181-002 | GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | |
| A078181-003 | GLIMEPIRIDE | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078181-001 | AB |
| A078181-002 | AB |
| A078181-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | 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 | A078181-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078181-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078181-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078181-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078181-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078181-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078181-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078181-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078181-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078181-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078181-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078181-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078181-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078181-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078181-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078181-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078181-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078181-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078181-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078181-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078181-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078181-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078181-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078181-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078181-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078181-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078181-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078181-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078181-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078181-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078181-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078181-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078181-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078181-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078181-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078181-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078181-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078181-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078181-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078181-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Glimepiride | GLIMEPIRIDE | Bryant Ranch Prepack | 9e863f84-d6f2-4d61-8250-774569e84353 | 2026-05-19 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 58c4261e-e98f-4280-9562-2800956dff14 | 2026-01-07 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 1b3c7d74-f80b-4fb1-8dca-66880af5d3fc | 2026-01-07 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | Northwind Health Company, LLC | 3e81a39a-30bb-4d6d-82e1-17d7134365be | 2026-01-01 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | Northwind Health Company, LLC | f2f2d6da-eb40-4290-e053-2a95a90a6ca0 | 2026-01-01 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | Accord Healthcare Inc | 9b74fbac-9e04-4927-9981-1e3dace89c6d | 2025-10-17 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b | 2022-10-01 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 5a5747ea-cded-49ed-8807-dd3e2a1159e0 | 2022-10-01 | Warnings, Adverse reactions | 078181 ANDA078181 |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 68cb4fcd-5bc3-4f53-9085-86df6a4246d6 | 2022-04-01 | Warnings, Adverse reactions | 078181 ANDA078181 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2412-0 | 70518241200 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2412-0) | 90 tablet | 2019-11-10 | 0000-00-00 | No | No | Current |
| 70518-2412-1 | 70518241201 | 180 TABLET in 1 BOTTLE, PLASTIC (70518-2412-1) | 180 tablet | 2020-02-17 | 0000-00-00 | No | No | Current |