Glipizide and Metformin Hydrochloride
- Product NDC
- 68382-186
- 11-digit product format
- 683820186
- Labeler code
- 68382
- Product ID
- 68382-186_e7654a95-e73f-4bfb-b7cd-eb85450d8c4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glipizide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA078905
- Marketing category
- ANDA
- Marketing start
- 2016-05-05
- Substance
- GLIPIZIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 5; 500 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glipizide and Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLIPIZIDE | 5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X7WDT95N5C, 786Z46389E |
| Rxcui | 861731, 861736, 861740 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-186-01 | Glipizide and Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 68382-186-10 | Glipizide and Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 68382-186-16 | Glipizide and Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 68382-186-30 | Glipizide and Metformin Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 68382-186-77 | Glipizide and Metformin Hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-186 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 5 package rows | 20241207_1b18b903-eb52-4d08-b4a5-f984957eb116.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-186-01 | 68382018601 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-186-01) | | 2016-05-05 | 0000-00-00 | No | No | Current |
| 68382-186-10 | 68382018610 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-186-10) | | 2016-05-05 | 0000-00-00 | No | No | Current |
| 68382-186-16 | 68382018616 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-186-16) | | 2016-05-05 | 0000-00-00 | No | No | Current |
| 68382-186-30 | 68382018630 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-186-77 | 68382018677 | 10 BLISTER PACK in 1 CARTON (68382-186-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-186-30) | 10 blister pack | 2016-05-05 | 0000-00-00 | No | No | Current |