NDC 0597-0182
Glyxambi
Empagliflozin And Linagliptin
Glyxambi is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Empagliflozin; Linagliptin.
| Product ID | 0597-0182_212797a6-c73f-415e-a983-a9e8a8b120a7 |
| NDC | 0597-0182 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Glyxambi |
| Generic Name | Empagliflozin And Linagliptin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-01-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA206073 |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | EMPAGLIFLOZIN; LINAGLIPTIN |
| Active Ingredient Strength | 10 mg/1; mg/1 |
| Pharm Classes | Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0597-0182-07
1 BOTTLE in 1 CARTON (0597-0182-07) > 7 TABLET, FILM COATED in 1 BOTTLE
| Marketing Start Date | 2015-01-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0597-0182-03 [00597018203]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-01-30 |
| Marketing End Date | 2016-09-30 |
NDC 0597-0182-07 [00597018207]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-01-30 |
NDC 0597-0182-30 [00597018230]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-30 |
NDC 0597-0182-70 [00597018270]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-01-30 |
| Marketing End Date | 2017-05-01 |
NDC 0597-0182-39 [00597018239]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-30 |
NDC 0597-0182-10 [00597018210]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-01-30 |
| Marketing End Date | 2017-01-05 |
NDC 0597-0182-90 [00597018290]
Glyxambi TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2015-01-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| EMPAGLIFLOZIN | 10 mg/1 |
OpenFDA Data
| SPL SET ID: | ddbab689-f76c-488c-9613-4168d41dd730 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Sodium-Glucose Transporter 2 Inhibitors [MoA]
- Dipeptidyl Peptidase 4 Inhibitors [MoA]
- Dipeptidyl Peptidase 4 Inhibitor [EPC]
NDC Crossover Matching brand name "Glyxambi" or generic name "Empagliflozin And Linagliptin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0597-0164 | Glyxambi | empagliflozin and linagliptin |
| 0597-0182 | Glyxambi | empagliflozin and linagliptin |
| 70518-2046 | Glyxambi | empagliflozin and linagliptin |
Trademark Results [Glyxambi]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLYXAMBI 79129593 4405329 Live/Registered |
Boehringer Ingelheim International GmbH 2013-03-20 |
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