Pioglitazone and metformin hydrochloride
- Product NDC
- 33342-177
- 11-digit product format
- 333420177
- Labeler code
- 33342
- Product ID
- 33342-177_c05a0d40-cee7-4a54-90e5-acd59e23f8f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pioglitazone and metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA204802
- Marketing category
- ANDA
- Marketing start
- 2015-11-06
- 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 and metformin hydrochloride
- Listing expiration
- 2027-12-31
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-177-09 | Pioglitazone and metformin hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 10 |
| 33342-177-11 | Pioglitazone and metformin hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
| 33342-177-12 | Pioglitazone and metformin hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 10 |
| 33342-177-12 | Pioglitazone and metformin hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 10 |
| 33342-177-44 | Pioglitazone and metformin hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 10 |
| 33342-177-57 | Pioglitazone and metformin hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-177 | PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 8 | Current NDC, Legacy NDC, 6 package rows | 20250510_5ff2cd9e-a579-48f5-845f-c37a68372a34.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 |
|---|
| 33342-177-09 | 33342017709 | 60 TABLET in 1 BOTTLE (33342-177-09) | 60 tablet | 2015-11-06 | 0000-00-00 | No | No | Current |
| 33342-177-11 | 33342017711 | 100 TABLET in 1 BOTTLE (33342-177-11) | 100 tablet | 2015-11-06 | 0000-00-00 | No | No | Current |
| 33342-177-12 | 33342017712 | 10 BLISTER PACK in 1 CARTON (33342-177-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2015-11-06 | 0000-00-00 | No | No | Current |
| 33342-177-44 | 33342017744 | 1000 TABLET in 1 BOTTLE (33342-177-44) | 1000 tablet | 2015-11-06 | 0000-00-00 | No | No | Current |
| 33342-177-57 | 33342017757 | 180 TABLET in 1 BOTTLE (33342-177-57) | 180 tablet | 2015-11-06 | 0000-00-00 | No | No | Current |