NDC 61168-101
KYBELLA
Deoxycholic Acid
KYBELLA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Kythera Biopharmaceuticals Inc.. The primary component is Deoxycholic Acid.
| Product ID | 61168-101_6af06e47-b62a-4521-90a9-e473476c26a9 |
| NDC | 61168-101 |
| Product Type | Human Prescription Drug |
| Proprietary Name | KYBELLA |
| Generic Name | Deoxycholic Acid |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2015-06-08 |
| Marketing Category | NDA / NDA |
| Application Number | NDA206333 |
| Labeler Name | Kythera Biopharmaceuticals Inc. |
| Substance Name | DEOXYCHOLIC ACID |
| Active Ingredient Strength | 20 mg/2mL |
| Pharm Classes | Cytolytic Agent [EPC],Decreased Cell Membrane Integrity [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 61168-101-03
2 VIAL, GLASS in 1 CARTON (61168-101-03) > 2 mL in 1 VIAL, GLASS
| Marketing Start Date | 2018-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
NDC SPL Data Element Entries
NDC 61168-101-01 [61168010101]
KYBELLA INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA206333 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-06-08 |
NDC 61168-101-94 [61168010194]
KYBELLA INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA206333 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-06-08 |
NDC 61168-101-04 [61168010104]
KYBELLA INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA206333 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2015-06-08 |
NDC 61168-101-91 [61168010191]
KYBELLA INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA206333 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-06-08 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| DEOXYCHOLIC ACID | 20 mg/2mL |
OpenFDA Data
| SPL SET ID: | fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Cytolytic Agent [EPC]
- Decreased Cell Membrane Integrity [PE]
- Cytolytic Agent [EPC]
- Decreased Cell Membrane Integrity [PE]
Trademark Results [KYBELLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KYBELLA 86128553 4795973 Live/Registered |
ALLERGAN SALES, LLC 2013-11-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.