Pioglitazone Hydrochloride and Metformin Hydrochloride
- Product NDC
- 57237-218
- 11-digit product format
- 572370218
- Labeler code
- 57237
- Product ID
- 57237-218_e1c4f0ca-4474-4bac-8884-8180e7aec050
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pioglitazone Hydrochloride and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA200823
- Marketing category
- ANDA
- Marketing start
- 2013-02-13
- Substance
- METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
- Active strength
- 850; 15 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pioglitazone Hydrochloride and Metformin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 850 mg/1 |
| PIOGLITAZONE HYDROCHLORIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, JQT35NPK6C |
| Rxcui | 861783, 861822 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57237-218-60 | Pioglitazone Hydrochloride and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 11 |
| 57237-218-81 | Pioglitazone Hydrochloride and Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-218 | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250305_8d252dab-e868-42d3-95ea-69423d909e84.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57237-218-60 | 57237021860 | 60 TABLET, FILM COATED in 1 BOTTLE (57237-218-60) | 2013-02-13 | 0000-00-00 | No | No | Current |
| 57237-218-81 | 57237021881 | 180 TABLET, FILM COATED in 1 BOTTLE (57237-218-81) | 2013-02-13 | 0000-00-00 | No | No | Current |