KYBELLA

Product NDC: 61168-101
Requested package NDC: 61168-101-94
11-digit product format: 611680101
Labeler code: 61168
Product ID: 61168-101_8125c34a-6f8e-47d8-bcd2-1b8cf1ce8a7a
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61168-101	61168-101-94	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206333-001	KYBELLA	DEOXYCHOLIC ACID	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N206333-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206333-001	7622130	2027-12-10	U-1690		2015-05-07
N206333-001	7754230	2027-12-10	U-1690		2015-05-07
N206333-001	8461140	2028-02-21		Drug product	2015-05-07
N206333-001	8546367	2028-02-21	U-1690	Drug product	2015-05-27
N206333-001	8883770	2028-02-21		Drug product	2015-05-27
N206333-001	9522155	2028-02-21	U-1940	Drug product	2017-01-19
N206333-001	9636349	2028-02-21	U-1940		2017-08-29
N206333-001	9949986	2028-02-21	U-1940		2018-05-24
N206333-001	8242294	2028-05-16		Drug substance	2015-05-07
N206333-001	10500214	2030-03-02		Drug product	2020-01-22
N206333-001	8101593	2030-03-02		Drug product	2015-05-07
N206333-001	8367649	2030-03-02		Drug product	2015-05-07
N206333-001	8653058	2030-03-02		Drug product	2015-05-07
N206333-001	12161653	2032-02-17	U-1940		2025-01-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2015-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N206333-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206333-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206333-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206333-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206333-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206333-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206333-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206333-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206333-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206333-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206333-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206333-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206333-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206333-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206333-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206333-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206333-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206333-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N206333-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206333-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206333-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206333-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206333-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206333-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206333-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206333-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206333-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206333-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206333-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206333-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206333-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206333-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206333-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206333-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206333-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 641 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206333-001	7622130	2027-12-10	U-1690		2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	7754230	2027-12-10	U-1690		2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8461140	2028-02-21		Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8546367	2028-02-21	U-1690	Drug product	2015-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8883770	2028-02-21		Drug product	2015-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	9522155	2028-02-21	U-1940	Drug product	2017-01-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	9636349	2028-02-21	U-1940		2017-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	9949986	2028-02-21	U-1940		2018-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8242294	2028-05-16		Drug substance	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	10500214	2030-03-02		Drug product	2020-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8101593	2030-03-02		Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8367649	2030-03-02		Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	8653058	2030-03-02		Drug product	2015-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206333-001	12161653	2032-02-17	U-1940		2025-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206333-001	7622130	2027-12-10	U-1690		2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	7754230	2027-12-10	U-1690		2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8461140	2028-02-21		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8546367	2028-02-21	U-1690	Drug product	2015-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8883770	2028-02-21		Drug product	2015-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	9522155	2028-02-21	U-1940	Drug product	2017-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	9636349	2028-02-21	U-1940		2017-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	9949986	2028-02-21	U-1940		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8242294	2028-05-16		Drug substance	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	10500214	2030-03-02		Drug product	2020-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8101593	2030-03-02		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8367649	2030-03-02		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	8653058	2030-03-02		Drug product	2015-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206333-001	12161653	2032-02-17	U-1940		2025-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206333-001	7622130	2027-12-10	U-1690		2015-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	7754230	2027-12-10	U-1690		2015-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8461140	2028-02-21		Drug product	2015-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8546367	2028-02-21	U-1690	Drug product	2015-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8883770	2028-02-21		Drug product	2015-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	9522155	2028-02-21	U-1940	Drug product	2017-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	9636349	2028-02-21	U-1940		2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	9949986	2028-02-21	U-1940		2018-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8242294	2028-05-16		Drug substance	2015-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	10500214	2030-03-02		Drug product	2020-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8101593	2030-03-02		Drug product	2015-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8367649	2030-03-02		Drug product	2015-05-07	`011fe1cb6892…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: KYBELLA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEOXYCHOLIC ACID	20 mg/2mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
39cdeb64-f113-4e85-b7f0-4953949e9750	Product name	2	20211014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61168-101-01	KYBELLA	2 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	2	25
61168-101-03	KYBELLA	2 in 1 CARTON	INJECTION, SOLUTION	2	25
61168-101-03	KYBELLA	2 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	2	25
61168-101-04	KYBELLA	4 in 1 CARTON	INJECTION, SOLUTION	4	25
61168-101-91	KYBELLA	2 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	2	25
61168-101-94	KYBELLA	4 in 1 CARTON	INJECTION, SOLUTION	4	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61168-101-01	ML - Milliliter	61168-101	aa9b0839-39b8-403c-a243-24eb341f3cf5	1	2016-11-08
61168-101-04	ML - Milliliter	61168-101	45fe77b6-e7f4-4c8f-b492-3c4baab536e7	1	2016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Deoxycholic Acid	ACTIVE INGREDIENT	005990WHZZ	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Deoxycholic Acid	ACTIVE MOIETY	005990WHZZ	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61168-101	KYBELLA (DEOXYCHOLIC ACID) INJECTION, SOLUTION [KYTHERA BIOPHARMACEUTICALS INC.]	24	Current NDC, Legacy NDC, 6 package rows	20250321_fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
005990WHZZ	DEOXYCHOLIC ACID	83-44-3	DEOXYCHOLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649975	deoxycholic acid 20 MG in 2 ML Injection	PSN	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25
1649980	Kybella 20 MG in 2 ML Injection	PSN	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25
1649980	2 ML deoxycholic acid 10 MG/ML Injection [Kybella]	SBD	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25
1649975	2 ML deoxycholic acid 10 MG/ML Injection	SCD	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25
1649980	2 ML Kybella 10 MG/ML Injection	SY	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25
1649975	deoxycholic acid 20 MG per 2 ML Injection	SY	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25
1649980	Kybella 20 MG per 2 ML Injection	SY	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61168-101-94	61168010194	4 VIAL, GLASS in 1 CARTON (61168-101-94) > 2 mL in 1 VIAL, GLASS (61168-101-91)	2015-06-08	2022-01-30	No	No	Current