XARACOLL

Product NDC: 51715-100
11-digit product format: 517150100
Labeler code: 51715
Product ID: 51715-100_23477215-fcfc-4b11-a5c3-b2034c31aefb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine HCl Collagen-matrix
Dosage form: IMPLANT
Route: PARENTERAL
Labeler: INNOCOLL PHARMACEUTICALS
Application: NDA209511
Marketing category: NDA
Marketing start: 2020-08-28
Marketing end: 0000-00-00
Substance: BUPIVACAINE
Active strength: 100 mg/1
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51715-100		I	Inactivated by FDA	2026-08-17
excluded package	package	51715-100	51715-100-04	I	Inactivated by FDA	2026-08-17
excluded package	package	51715-100	51715-100-10	I	Inactivated by FDA	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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51715-100-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51715-100-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51715-100-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51715-100-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51715-100-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51715-100-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51715-100-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51715-100-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51715-100-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51715-100-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51715-100-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51715-100-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51715-100-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51715-100-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51715-100-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51715-100-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51715-100-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51715-100-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51715-100-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51715-100-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51715-100-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51715-100-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51715-100-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51715-100-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51715-100-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	51715-100-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51715-100-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	51715-100-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51715-100-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	51715-100-10	`1332a3947898…`	`d4bfe170f9cd…`

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
N209511-001	XARACOLL	BUPIVACAINE HYDROCHLORIDE	100MG	IMPLANT / IMPLANTATION		RLD	2020-08-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209511-001	RE47826	2029-05-20	U-2949		2020-09-28
N209511-001	11746141	2033-01-09		Drug product	2023-09-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD, RS	2020-08-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209511-001	XARACOLL	100MG	IMPLANT / IMPLANTATION	RLD	2020-08-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 59 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	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209511-001	11746141	2033-01-09		Drug product	2023-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209511-001	RE47826	2029-05-20	U-2949		2020-09-28	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209511-001	NP	2023-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209511-001	NP	2023-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209511-001	NP	2023-08-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209511-001	NP	2023-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209511-001	NP	2023-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209511-001	NP	2023-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209511-001	NP	2023-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209511-001	NP	2023-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209511-001	NP	2023-08-28	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N209511-001	NP	2023-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209511-001	NP	2023-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209511-001	NP	2023-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209511-001	NP	2023-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209511-001	NP	2023-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209511-001	NP	2023-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209511-001	NP	2023-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209511-001	NP	2023-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209511-001	NP	2023-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209511-001	NP	2023-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209511-001	NP	2023-08-28	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51715-100-04	2024-01-30	C162847	48780-1	1030e365-4752-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use XARACOLL ® safely and effectively. See full prescribing information for XARACOLL. XARACOLL ® (bupivacaine hydrochloride) implant Initial U.S. Approval: 1972
51715-100-10	2024-01-30	C162847	48780-1	1030e365-4752-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use XARACOLL ® safely and effectively. See full prescribing information for XARACOLL. XARACOLL ® (bupivacaine hydrochloride) implant Initial U.S. Approval: 1972

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51715-100-04	XARACOLL	1 in 1 CARTON	IMPLANT	1	4
51715-100-04	XARACOLL	4 in 1 CARTON	IMPLANT	4	4
51715-100-10	XARACOLL	1 in 1 CARTON	IMPLANT	1	4
51715-100-10	XARACOLL	10 in 1 CARTON	IMPLANT	10	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51715-100	XARACOLL (BUPIVACAINE HCL COLLAGEN-MATRIX) IMPLANT [INNOCOLL PHARMACEUTICALS]	4	Legacy NDC, 4 package rows	20200912_46da5733-c892-43a5-b826-1898a753f1c3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y8335394RO	BUPIVACAINE	38396-39-3	BUPIVACAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2395798	{3 (bupivacaine hydrochloride 100 MG Drug Implant [Xaracoll]) } Pack [Xaracoll 3 Implant Dose]	BPCK	46da5733-c892-43a5-b826-1898a753f1c3	4
2395792	{3 (bupivacaine hydrochloride 100 MG Drug Implant) } Pack	GPCK	46da5733-c892-43a5-b826-1898a753f1c3	4
2395791	BUPivacaine HCl 100 MG Drug Implant	PSN	46da5733-c892-43a5-b826-1898a753f1c3	4
2395792	BUPivacaine HCl 100 MG Drug Implant, 3 Implant Dose	PSN	46da5733-c892-43a5-b826-1898a753f1c3	4
2395797	Xaracoll 100 MG Drug Implant	PSN	46da5733-c892-43a5-b826-1898a753f1c3	4
2395798	xaracoll 3 x 100 MG Implant Dose Pack	PSN	46da5733-c892-43a5-b826-1898a753f1c3	4
2395797	bupivacaine hydrochloride 100 MG Drug Implant [Xaracoll]	SBD	46da5733-c892-43a5-b826-1898a753f1c3	4
2395791	bupivacaine hydrochloride 100 MG Drug Implant	SCD	46da5733-c892-43a5-b826-1898a753f1c3	4
2395792	bupivacaine HCl 100 MG Drug Implant, 3 Implant Dose	SY	46da5733-c892-43a5-b826-1898a753f1c3	4
2395792	bupivacaine hydrochloride 100 MG Drug Implant, 3 Implant Dose	SY	46da5733-c892-43a5-b826-1898a753f1c3	4
2395797	Xaracoll 100 MG Drug Implant	SY	46da5733-c892-43a5-b826-1898a753f1c3	4
2395798	xaracoll 3 x 100 MG Implant Dose Pack	SY	46da5733-c892-43a5-b826-1898a753f1c3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51715-100-04	51715010004	4 CARTON in 1 CARTON (51715-100-04) > 1 POUCH in 1 CARTON > 3 IMPLANT in 1 POUCH	4 carton	2020-08-28	0000-00-00	No	No	Current
51715-100-10	51715010010	10 CARTON in 1 CARTON (51715-100-10) > 1 POUCH in 1 CARTON > 3 IMPLANT in 1 POUCH	10 carton	2020-08-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XARACOLL - INNOCOLL PHARMACEUTICALS \| Innocoll Pharmaceuticals Limited \| Syntacoll GmbH	INNOCOLL PHARMACEUTICALS \| Innocoll Pharmaceuticals Limited \| Syntacoll GmbH	2020-09-08	HUMAN PRESCRIPTION DRUG LABEL	4