Glimepiride
- Product NDC
- 0615-6576
- 11-digit product format
- 006156576
- Labeler code
- 0615
- Product ID
- 0615-6576_9b447065-35ee-4312-9f1e-ac4b4739254b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA077091
- Marketing category
- ANDA
- Marketing start
- 2005-10-06
- Marketing end
- 0000-00-00
- Substance
- GLIMEPIRIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 0615-6576 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0615-6576 | 0615-6576-39 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077091-001 | GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 |
| A077091-002 | GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | |
| A077091-003 | GLIMEPIRIDE | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077091-001 | AB |
| A077091-002 | AB |
| A077091-003 | 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 | A077091-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | RS | 2005-10-06 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077091-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2005-10-06 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A077091-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2005-10-06 | 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 | A077091-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077091-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A077091-003 | 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 | Cardinal Health 107, LLC | cc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa | 2026-05-08 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | NuCare Pharmaceuticals,Inc. | bf8e5993-5ee7-d26d-e053-2a95a90ae5df | 2026-02-19 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | AvPAK | 93f1e064-fcbd-e8fd-e053-2995a90a5dbb | 2026-01-14 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Northwind Health Company, LLC | f3184cd3-df99-db32-e053-2995a90aa573 | 2026-01-01 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Northwind Health Company, LLC | dae404ac-881a-14d8-e053-2995a90acd41 | 2026-01-01 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 101cdc41-2131-4425-b550-6a0a60b5f4a4 | 2025-10-15 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 657f1b51-2f82-44f6-a23d-97f4b34b3c45 | 2025-10-15 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | American Health Packaging | 0003458f-352a-46fa-9d99-230daa76ae29 | 2024-11-13 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Proficient Rx LP | 1f102e4c-1954-4f17-8c60-4dad79f25a25 | 2024-09-01 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | NuCare Pharmaceuticals,Inc. | abc187f1-8645-23e9-e053-2a95a90a64a7 | 2024-07-17 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | be772fca-1579-4fba-a4b7-04b970d09e45 | 2023-12-17 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | 0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b | 2023-12-14 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | a9461830-1c4f-4bc4-b622-1c44112a76b9 | 2023-12-03 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | A-S Medication Solutions | def20e38-01f7-4ead-beb6-3dc11062a342 | 2023-06-22 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Bryant Ranch Prepack | ebb9f080-b11d-5d18-36f0-627107e7fbcd | 2020-08-27 | Warnings, Adverse reactions | 077091 ANDA077091 |
| Glimepiride | GLIMEPIRIDE | Dr. Reddy's Laboratories Limited | 07ad4366-4b21-f633-49f3-c2b35f88168d | 2019-01-16 | Warnings, Adverse reactions | 077091 ANDA077091 |