Glimepiride
- Product NDC
- 16729-001
- Requested package NDC
- 16729-001-01
- 11-digit product format
- 167290001
- Labeler code
- 16729
- Product ID
- 16729-001_415deb6c-47dc-ed2a-e063-6394a90a66fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glimepiride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc
- Application
- ANDA078181
- Marketing category
- ANDA
- Marketing start
- 2007-08-23
- 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 |
|---|---|---|---|---|---|---|---|
| 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… |
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 |
|---|---|
| 9b74fbac-9e04-4927-9981-1e3dace89c6d | 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 |
|---|---|---|---|---|---|---|
| 16729-001-01 | Glimepiride | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 16729-001-16 | Glimepiride | 500 in 1 BOTTLE | TABLET | 500 | 10 | |
| 16729-001-17 | Glimepiride | 1000 in 1 BOTTLE | TABLET | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-001-01 | EA - Each | 16729-001 | 72e554c4-b3db-49ed-8edd-1fec16eaa293 | 1 | 2013-02-13 |
| 16729-001-16 | EA - Each | 16729-001 | 1d24ee34-12a2-4ffa-9acf-56d35264abd6 | 1 | 2016-10-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLIMEPIRIDE | ACTIVE INGREDIENT | 6KY687524K | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| GLIMEPIRIDE | ACTIVE MOIETY | 6KY687524K | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GLIMEPIRIDE TABLET [ACCORD HEALTHCARE INC] | 4 |
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 | 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 16729-001-01 16729-001 16729000101 |
| 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 RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16729-001-01 | 16729000101 | 100 TABLET in 1 BOTTLE (16729-001-01) | 100 tablet | 2007-08-23 | 0000-00-00 | No | No | Current |