Jentadueto
- Product NDC
- 0597-0147
- 11-digit product format
- 005970147
- Labeler code
- 0597
- Product ID
- 0597-0147_f5fe93f0-69ef-4ca2-adeb-c50582e25592
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- linagliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA201281
- Marketing category
- NDA
- Marketing start
- 2012-02-13
- Substance
- LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- Active strength
- 2.5; 850 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LINAGLIPTIN | 2.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, 3X29ZEJ4R2 |
| Rxcui | 1243020, 1243026, 1243027, 1243033, 1243034, 1243040 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0597-0147-18 | Jentadueto | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 45 |
| 0597-0147-60 | Jentadueto | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 45 |
| 0597-0147-66 | Jentadueto | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 45 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| linagliptin | ACTIVE INGREDIENT | 3X29ZEJ4R2 | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| metformin hydrochloride | ACTIVE INGREDIENT | 786Z46389E | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| linagliptin | ACTIVE MOIETY | 3X29ZEJ4R2 | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| metformin | ACTIVE MOIETY | 9100L32L2N | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| arginine | INACTIVE INGREDIENT | 94ZLA3W45F | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| copovidone | INACTIVE INGREDIENT | D9C330MD8B | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | JENTADUETO (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 28 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0597-0147 | JENTADUETO (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 45 | Current NDC, Legacy NDC, 3 package rows | 20240822_f6dd9b86-0d18-95d4-2bc7-05591bfdd597.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 |
|---|
| 0597-0147-18 | 00597014718 | 180 TABLET, FILM COATED in 1 BOTTLE (0597-0147-18) | 2012-02-13 | 0000-00-00 | No | No | Current |
| 0597-0147-60 | 00597014760 | 60 TABLET, FILM COATED in 1 BOTTLE (0597-0147-60) | 2012-02-13 | 0000-00-00 | No | No | Current |
| 0597-0147-66 | 00597014766 | 14 TABLET, FILM COATED in 1 BOTTLE (0597-0147-66) | 2012-02-13 | 0000-00-00 | No | No | Current |