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

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		2026-08-17

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 42.

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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	N206333-001	KYBELLA	20MG/2ML (10MG/ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2015-04-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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 16 · 627 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2026-02-19 14:30 UTC	2026-02	N206333-001	8653058	2030-03-02		Drug product	2015-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206333-001	12161653	2032-02-17	U-1940		2025-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	8846066	2025-02-08	U-1690		2015-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	8298556	2025-08-03	U-1690		2015-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	7622130	2027-12-10	U-1690		2015-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	7754230	2027-12-10	U-1690		2015-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	8461140	2028-02-21		Drug product	2015-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	8546367	2028-02-21	U-1690	Drug product	2015-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	8883770	2028-02-21		Drug product	2015-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	9522155	2028-02-21	U-1940	Drug product	2017-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	9636349	2028-02-21	U-1940		2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	9949986	2028-02-21	U-1940		2018-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	8242294	2028-05-16		Drug substance	2015-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206333-001	10500214	2030-03-02		Drug product	2020-01-22	`31067a03dcf5…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
005990WHZZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1649975	Internal RxNorm lookup
1649980	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KYBELLA	DEOXYCHOLIC ACID	Kythera Biopharmaceuticals Inc.	fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206333 application number: NDA206333 ndc (product): 61168-101

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61168-101-01	61168010101	2 mL in 1 VIAL, GLASS	2 ml					Historical
61168-101-03	61168010103	2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS		2018-08-01	0000-00-00	Yes	No	Current
61168-101-04	61168010104	4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01)		2015-06-08	0000-00-00	No	No	Current
61168-101-91	61168010191	2 mL in 1 VIAL, GLASS	2 ml					Historical
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