Glyxambi
- Product NDC
- 0597-0182
- 11-digit product format
- 005970182
- Labeler code
- 0597
- Product ID
- 0597-0182_16f275d5-7526-4e7a-8776-665a9a6ae37a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- empagliflozin and linagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- NDA206073
- Marketing category
- NDA
- Marketing start
- 2015-01-30
- Substance
- EMPAGLIFLOZIN; LINAGLIPTIN
- Active strength
- 10; 5 mg/1; mg/1
- Pharmacologic classes
- Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glyxambi
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EMPAGLIFLOZIN | 10 mg/1 |
| LINAGLIPTIN | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDC1R2M35U, 3X29ZEJ4R2 |
| Rxcui | 1602109, 1602115, 1602118, 1602120 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0597-0182-03 | Glyxambi | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 0597-0182-07 | Glyxambi | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 23 |
| 0597-0182-07 | Glyxambi | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 23 |
| 0597-0182-30 | Glyxambi | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
| 0597-0182-39 | Glyxambi | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 23 |
| 0597-0182-39 | Glyxambi | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 23 |
| 0597-0182-70 | Glyxambi | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 23 |
| 0597-0182-70 | Glyxambi | 7 in 1 CARTON | TABLET, FILM COATED | 7 | | 23 |
| 0597-0182-90 | Glyxambi | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| empagliflozin | ACTIVE INGREDIENT | HDC1R2M35U | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| linagliptin | ACTIVE INGREDIENT | 3X29ZEJ4R2 | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| empagliflozin | ACTIVE MOIETY | HDC1R2M35U | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| linagliptin | ACTIVE MOIETY | 3X29ZEJ4R2 | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| copovidone | INACTIVE INGREDIENT | D9C330MD8B | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | GLYXAMBI (EMPAGLIFLOZIN LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0597-0182 | GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 21 | Current NDC, Legacy NDC, 9 package rows | 20240713_ddbab689-f76c-488c-9613-4168d41dd730.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 |
|---|
| 0597-0182-03 | 00597018203 | 30 in 1 BOTTLE | | | | | | Historical |
| 0597-0182-07 | 00597018207 | 1 BOTTLE in 1 CARTON (0597-0182-07) > 7 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-01-30 | 0000-00-00 | No | No | Current |
| 0597-0182-30 | 00597018230 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0182-30) | | 2015-01-30 | 0000-00-00 | No | No | Current |
| 0597-0182-39 | 00597018239 | 30 BLISTER PACK in 1 CARTON (0597-0182-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2015-01-30 | 0000-00-00 | No | No | Current |
| 0597-0182-70 | 00597018270 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0597-0182-90 | 00597018290 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0182-90) | | 2015-01-30 | 0000-00-00 | No | No | Current |