Glipizide and Metformin HCl
- Product NDC
- 23155-115
- 11-digit product format
- 231550115
- Labeler code
- 23155
- Product ID
- 23155-115_c4bfb4e7-c864-46ac-8317-ecdc8d16aaa7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glipizide and Metformin HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA078728
- Marketing category
- ANDA
- Marketing start
- 2010-06-29
- Substance
- GLIPIZIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 2.5; 250 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | |
| A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | |
| A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078728-001 | AB |
| A078728-002 | AB |
| A078728-003 | 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 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078728-002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078728-003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET / ORAL | AB | 2010-06-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078728-001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | 2.5MG;250MG | TABLET / ORAL | AB | 2010-06-23 | 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 | A078728-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078728-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078728-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078728-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078728-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078728-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078728-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078728-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078728-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078728-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078728-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078728-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078728-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078728-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078728-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078728-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078728-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078728-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078728-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078728-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078728-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078728-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078728-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078728-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078728-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078728-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078728-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078728-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078728-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078728-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078728-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078728-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078728-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078728-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078728-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078728-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078728-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078728-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078728-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078728-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glipizide and Metformin HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLIPIZIDE | 2.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X7WDT95N5C | Internal UNII lookup |
| 786Z46389E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 94a7f96e-2ed1-432d-bc6a-5840863816e1 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 23155-115-01 | Glipizide and Metformin HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 15 | |
| 23155-115-10 | Glipizide and Metformin HCl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 23155-115-01 | EA - Each | 23155-115 | 4d65ec12-bf88-40bd-bea5-cd556757ac94 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 23155-115 | GLIPIZIDE AND METFORMIN HCL TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241206_94a7f96e-2ed1-432d-bc6a-5840863816e1.zip |
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 |
|---|---|---|---|---|---|---|
| Glipizide and Metformin HCl | GLIPIZIDE AND METFORMIN HCL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 078728 ANDA078728 23155-115 |
| Glipizide and metformin hcl | GLIPIZIDE AND METFORMIN HCL | Chartwell RX, LLC | ac018f64-fd9d-4b3c-b0ac-ca305b8df635 | 2025-12-10 | Boxed warning, Adverse reactions | 078728 ANDA078728 |
| Glipizide and Metformin HCl | GLIPIZIDE AND METFORMIN HCL | Proficient Rx LP | be4d2552-c964-4d09-ba7a-0d94320f968c | 2019-10-01 | Warnings, Adverse reactions | 078728 ANDA078728 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861731 | glipiZIDE 2.5 MG / metFORMIN HCl 250 MG Oral Tablet | PSN | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 15 |
| 861736 | glipiZIDE 2.5 MG / metFORMIN HCl 500 MG Oral Tablet | PSN | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 15 |
| 861740 | glipiZIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet | PSN | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 15 |
| 861731 | glipizide 2.5 MG / metformin hydrochloride 250 MG Oral Tablet | SCD | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 15 |
| 861736 | glipizide 2.5 MG / metformin hydrochloride 500 MG Oral Tablet | SCD | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 15 |
| 861740 | glipizide 5 MG / metformin hydrochloride 500 MG Oral Tablet | SCD | 94a7f96e-2ed1-432d-bc6a-5840863816e1 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 23155-115-01 | 23155011501 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-115-01) | 2010-06-29 | 0000-00-00 | No | No | Current |
| 23155-115-10 | 23155011510 | 1000 TABLET, FILM COATED in 1 BOTTLE (23155-115-10) | 2010-06-29 | 0000-00-00 | No | No | Current |