FDA.reportPublic FDA data

KYBELLA

Product NDC
61168-101
11-digit product format
611680101
Labeler code
61168
Product ID
61168-101_c67c4873-6322-42dc-8a2b-da3a7012a435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Deoxycholic Acid
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Kythera Biopharmaceuticals Inc.
Application
NDA206333
Marketing category
NDA
Marketing start
2015-06-08
Substance
DEOXYCHOLIC ACID
Active strength
20 mg/2mL
Pharmacologic classes
Cytolytic Agent [EPC], Decreased Cell Membrane Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KYBELLA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEOXYCHOLIC ACID20 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii005990WHZZ
Rxcui1649975, 1649980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
39cdeb64-f113-4e85-b7f0-4953949e9750Product name220211014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61168-101-01KYBELLA2 mL in 1 VIAL, GLASSINJECTION, SOLUTION225
61168-101-03KYBELLA2 in 1 CARTONINJECTION, SOLUTION225
61168-101-03KYBELLA2 mL in 1 VIAL, GLASSINJECTION, SOLUTION225
61168-101-04KYBELLA4 in 1 CARTONINJECTION, SOLUTION425
61168-101-91KYBELLA2 mL in 1 VIAL, GLASSINJECTION, SOLUTION225
61168-101-94KYBELLA4 in 1 CARTONINJECTION, SOLUTION425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61168-101KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]24Current NDC, Legacy NDC, 6 package rows20250321_fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649975deoxycholic acid 20 MG in 2 ML InjectionPSNfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325
1649980Kybella 20 MG in 2 ML InjectionPSNfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325
16499802 ML deoxycholic acid 10 MG/ML Injection [Kybella]SBDfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325
16499752 ML deoxycholic acid 10 MG/ML InjectionSCDfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325
16499802 ML Kybella 10 MG/ML InjectionSYfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325
1649975deoxycholic acid 20 MG per 2 ML InjectionSYfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325
1649980Kybella 20 MG per 2 ML InjectionSYfe431ed4-ea6f-4e99-b4bc-ec25ae7b855325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61168-101-01611680101012 mL in 1 VIAL, GLASS2 mlHistorical
61168-101-03611680101032 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS2018-08-010000-00-00YesNoCurrent
61168-101-04611680101044 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01) 2015-06-080000-00-00NoNoCurrent
61168-101-91611680101912 mL in 1 VIAL, GLASS2 mlHistorical
61168-101-94611680101944 VIAL, GLASS in 1 CARTON (61168-101-94) > 2 mL in 1 VIAL, GLASS (61168-101-91) 2015-06-082022-01-30NoNoCurrent