Glimepiride
- Product NDC
- 68788-8066
- 11-digit product format
- 687888066
- Labeler code
- 68788
- Product ID
- 68788-8066_9daf0202-6c94-4b42-9bc6-3e473c771b63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2021-08-16
- Marketing end
- 0000-00-00
- Substance
- GLIMEPIRIDE
- Active strength
- 4 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 | 68788-8066 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-8066 | 68788-8066-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-8066 | 68788-8066-6 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-8066 | 68788-8066-9 | D | Discontinued by firm | 2026-08-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A078181-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2007-08-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078181-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2007-08-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078181-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2007-08-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A078181-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078181-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078181-003 | AB | 1 | a50c72e98297… |
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 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8066 | GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20240511_fc359d31-ef3d-4d6f-bd5a-8636f8211aea.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-8066-3 | 68788806603 | 30 TABLET in 1 BOTTLE (68788-8066-3) | 30 tablet | 2021-08-16 | 0000-00-00 | No | No | Current |
| 68788-8066-6 | 68788806606 | 60 TABLET in 1 BOTTLE (68788-8066-6) | 60 tablet | 2021-08-16 | 0000-00-00 | No | No | Current |
| 68788-8066-9 | 68788806609 | 90 TABLET in 1 BOTTLE (68788-8066-9) | 90 tablet | 2021-08-16 | 0000-00-00 | No | No | Current |