Pioglitazone
- Product NDC
- 68151-3798
- 11-digit product format
- 681513798
- Labeler code
- 68151
- Product ID
- 68151-3798_7b3823e9-474e-47d6-841f-ff75f0fb3052
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pioglitazone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- NDA021073
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-08-17
- Marketing end
- 0000-00-00
- Substance
- PIOGLITAZONE HYDROCHLORIDE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e11f0f31-8914-938f-521e-037b6de27c13 | Product name | 5 | 20210621 |
| 3e9b6ece-066b-2ac3-28f7-5e13060e5934 | Product name | 2 | 20151109 |
| 0d79b284-47e8-e90c-f249-892b9b251003 | Product name | 1 | 20140508 |
| 7611093e-8875-33d4-9e3c-f48c7e3af1e8 | Product name | 1 | 20140508 |
| ac29cd77-922c-d25a-f8ad-66a8692935c5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-3798-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-73d8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-3798-9 | Pioglitazone | 1 in 1 PACKAGE | TABLET | 1 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| pioglitazone hydrochloride | ACTIVE INGREDIENT | JQT35NPK6C | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| pioglitazone | ACTIVE MOIETY | X4OV71U42S | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CARBOXYMETHYLCELLULOSE CALCIUM | INACTIVE INGREDIENT | UTY7PDF93L | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-3798 | PIOGLITAZONE TABLET [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20140815_7547c308-3c83-429c-b761-0610d775317d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312440 | pioglitazone 30 MG Oral Tablet | PSN | 7547c308-3c83-429c-b761-0610d775317d | 2 |
| 312440 | pioglitazone 30 MG Oral Tablet | SCD | 7547c308-3c83-429c-b761-0610d775317d | 2 |
| 312440 | pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet | SY | 7547c308-3c83-429c-b761-0610d775317d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-3798-9 | 68151379809 | 1 in 1 PACKAGE | Historical |