Jentadueto XR
- Product NDC
- 0597-0270
- 11-digit product format
- 005970270
- Labeler code
- 0597
- Product ID
- 0597-0270_bded948b-6ae6-41aa-bc63-9600660a8dfc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- linagliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA208026
- Marketing category
- NDA
- Marketing start
- 2016-05-27
- Substance
- LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- Active strength
- 2.5; 1000 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Jentadueto XR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LINAGLIPTIN | 2.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 3X29ZEJ4R2 |
| Rxcui | 1796089, 1796091, 1796094, 1796096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0597-0270-12 | Jentadueto XR | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 9 |
| 0597-0270-12 | Jentadueto XR | 14 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 14 | | 9 |
| 0597-0270-73 | Jentadueto XR | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 9 |
| 0597-0270-94 | Jentadueto XR | 180 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 180 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0597-0270 | JENTADUETO XR (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240606_3d02a4d4-d312-80b4-05c4-691b8f0aa7aa.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 |
|---|
| 0597-0270-12 | 00597027012 | 1 BOTTLE in 1 CARTON (0597-0270-12) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2016-05-27 | 0000-00-00 | No | No | Current |
| 0597-0270-73 | 00597027073 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-73) | | 2016-05-27 | 0000-00-00 | No | No | Current |
| 0597-0270-94 | 00597027094 | 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0270-94) | | 2016-05-27 | 0000-00-00 | No | No | Current |