Pioglitazone Hydrochloride and Metformin Hydrochloride
- Product NDC
- 65862-526
- 11-digit product format
- 658620526
- Labeler code
- 65862
- Product ID
- 65862-526_1468f2ff-4355-402a-8c46-0b9272ae633e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pioglitazone Hydrochloride and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- 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 |
|---|
| 65862-526-18 | Pioglitazone Hydrochloride and Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 14 |
| 65862-526-60 | Pioglitazone Hydrochloride and Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| PIOGLITAZONE HYDROCHLORIDE | ACTIVE INGREDIENT | JQT35NPK6C | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| PIOGLITAZONE | ACTIVE MOIETY | X4OV71U42S | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| CARBOXYMETHYLCELLULOSE CALCIUM | INACTIVE INGREDIENT | UTY7PDF93L | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-526 | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250302_1fa2703e-fb73-44d5-aaa2-b12b1090d42c.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 |
|---|
| 65862-526-18 | 65862052618 | 180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18) | 2013-02-13 | 0000-00-00 | No | No | Current |
| 65862-526-60 | 65862052660 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-526-60) | 2013-02-13 | 0000-00-00 | No | No | Current |