Glimepiride
- Product NDC
- 61442-115
- 11-digit product format
- 614420115
- Labeler code
- 61442
- Product ID
- 61442-115_2386d706-9dab-4ae0-e063-6394a90a8a06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carlsbad Technology, Inc.
- Application
- ANDA077911
- Marketing category
- ANDA
- Marketing start
- 2012-01-01
- Substance
- GLIMEPIRIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077911-001 | GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | |
| A077911-002 | GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | |
| A077911-003 | GLIMEPIRIDE | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077911-001 | AB |
| A077911-002 | AB |
| A077911-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077911-002 | GLIMEPIRIDE | 2MG | TABLET / ORAL | AB | 2009-09-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077911-003 | GLIMEPIRIDE | 4MG | TABLET / ORAL | AB | 2009-09-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077911-001 | GLIMEPIRIDE | 1MG | TABLET / ORAL | AB | 2009-09-22 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077911-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077911-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077911-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077911-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077911-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077911-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077911-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077911-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077911-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077911-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077911-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077911-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077911-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077911-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077911-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077911-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077911-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077911-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077911-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077911-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077911-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077911-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077911-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077911-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077911-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077911-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077911-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077911-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077911-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077911-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077911-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077911-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077911-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077911-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077911-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077911-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077911-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077911-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077911-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077911-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glimepiride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLIMEPIRIDE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6KY687524K | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 72d88c6d-2f0a-4bf8-aa7f-1e1811794187 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b890b964-2cf0-4439-aaf3-900c9e3e9e49 | Product name | 1 | 20160602 |
| 7611093e-8875-33d4-9e3c-f48c7e3af1e8 | Product name | 1 | 20140508 |
| d36d861f-8a90-80cc-8935-1e6be9b4c7eb | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61442-115-01 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | 11 | |
| 61442-115-05 | Glimepiride | 500 in 1 BOTTLE | TABLET | 500 | 11 | |
| 61442-115-10 | Glimepiride | 1000 in 1 BOTTLE | TABLET | 1000 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61442-115-01 | EA - Each | 61442-115 | 653f21c0-52da-441b-8a61-1a072192eaef | 1 | 2012-07-24 |
| 61442-115-05 | EA - Each | 61442-115 | 07130041-0a3e-4c4c-8767-06f27ad2ef7e | 1 | 2016-06-14 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [CARLSBAD TECHNOLOGY, INC.] | 7 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 647a146c-c752-4589-8619-aed5c720ca54 | 2026-03-19 | Warnings, Adverse reactions | 077911 ANDA077911 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | ed7a3a8e-97dd-4a5a-9497-001acfd2f1f0 | 2026-03-19 | Warnings, Adverse reactions | 077911 ANDA077911 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | f4ffb19e-6d65-49fd-83ce-514d38d9d97c | 2025-02-04 | Warnings, Adverse reactions | 077911 ANDA077911 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 11ae3189-6139-4470-95d5-72abc0f5b0d0 | 2025-01-08 | Warnings, Adverse reactions | 077911 ANDA077911 |
| Glimepiride | GLIMEPIRIDE | PD-Rx Pharmaceuticals, Inc. | 2794f86b-d521-414b-8154-5dd1e2519653 | 2025-01-03 | Warnings, Adverse reactions | 077911 ANDA077911 |
| Glimepiride | GLIMEPIRIDE | Golden State Medical Supply, Inc. | 4f83e203-c102-47fa-bb8e-4fc5541e0d6f | 2024-12-05 | Warnings, Adverse reactions | 077911 ANDA077911 |
| Glimepiride | GLIMEPIRIDE | Carlsbad Technology, Inc. | 72d88c6d-2f0a-4bf8-aa7f-1e1811794187 | 2024-10-02 | Warnings, Adverse reactions | 077911 ANDA077911 61442-115 |
| Glimepiride | GLIMEPIRIDE | Aphena Pharma Solutions - Tennessee, LLC | 00b9e312-921e-41e6-ad27-0a6ce87f8298 | 2019-02-13 | Warnings, Adverse reactions | 077911 ANDA077911 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61442-115-01 | 61442011501 | 100 TABLET in 1 BOTTLE (61442-115-01) | 100 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 61442-115-05 | 61442011505 | 500 TABLET in 1 BOTTLE (61442-115-05) | 500 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 61442-115-10 | 61442011510 | 1000 TABLET in 1 BOTTLE (61442-115-10) | 1000 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |