DEFENCATH

Product NDC: 72990-103
Requested package NDC: 72990-103-10
11-digit product format: 729900103
Labeler code: 72990
Product ID: 72990-103_c4c34743-4c50-4dd2-836c-3669dcdcb349
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: taurolidine and heparin
Dosage form: SOLUTION
Route: INTRALUMINAL
Labeler: CorMedix Inc.
Application: NDA214520
Marketing category: NDA
Marketing start: 2024-04-09
Substance: TAUROLIDINE; HEPARIN
Active strength: 40.5; 3000 mg/3mL; [USP'U]/3mL
Pharmacologic classes: Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214520-001	DEFENCATH	HEPARIN SODIUM; TAUROLIDINE	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A		RLD, RS	2023-11-15
N214520-002	DEFENCATH	HEPARIN SODIUM; TAUROLIDINE	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A		RLD, RS	2023-11-15

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214520-001	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14
N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14
N214520-002	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14
N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214520-001	NCE	2028-11-15
N214520-001	GAIN	2033-11-15
N214520-002	NCE	2028-11-15
N214520-002	GAIN	2033-11-15

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
2026-09-14 22:38:34	2026-08	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / INJECTION	RLD, RS	2023-11-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / INJECTION	RLD, RS	2023-11-15	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214520-001	DEFENCATH	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214520-002	DEFENCATH	5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	SOLUTION / N/A	RLD, RS	2023-11-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 120 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	N214520-001	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-002	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214520-001	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-002	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214520-001	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-002	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-001	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-002	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214520-001	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-002	7696182	2026-05-16	U-3774	Drug substance, Drug product	2023-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-001	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-002	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-001	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-002	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	8541393	2024-11-02	U-3774	Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	9339036	2024-11-02		Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	8541393	2024-11-02	U-3774	Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	9339036	2024-11-02		Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	8541393	2024-11-02	U-3774	Drug substance, Drug product	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	9339036	2024-11-02		Drug substance, Drug product	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	7696182	2025-05-16	U-3774	Drug substance, Drug product	2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	11738120	2042-04-15		Drug substance, Drug product	2023-12-14	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214520-001	NCE	2028-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-001	GAIN	2033-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-002	NCE	2028-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214520-002	GAIN	2033-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214520-001	NCE	2028-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-001	GAIN	2033-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-002	NCE	2028-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214520-002	GAIN	2033-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214520-001	NCE	2028-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-001	GAIN	2033-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-002	NCE	2028-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214520-002	GAIN	2033-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-001	NCE	2028-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-001	GAIN	2033-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-002	NCE	2028-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214520-002	GAIN	2033-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214520-001	NCE	2028-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-001	GAIN	2033-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-002	NCE	2028-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214520-002	GAIN	2033-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-001	NCE	2028-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-001	GAIN	2033-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-002	NCE	2028-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214520-002	GAIN	2033-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-001	NCE	2028-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-001	GAIN	2033-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-002	NCE	2028-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214520-002	GAIN	2033-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	NCE	2028-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-001	GAIN	2033-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	NCE	2028-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214520-002	GAIN	2033-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	NCE	2028-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-001	GAIN	2033-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-002	NCE	2028-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214520-002	GAIN	2033-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214520-001	NCE	2028-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214520-001	GAIN	2033-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214520-002	NCE	2028-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214520-002	GAIN	2033-11-15	`5bbf6a4d5a75…`

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: DEFENCATH
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAUROLIDINE	40.5 mg/3mL
HEPARIN	3000 [USP'U]/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8OBZ1M4V3V	Internal UNII lookup
T2410KM04A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2670461	Internal RxNorm lookup
2670468	Internal RxNorm lookup
2670471	Internal RxNorm lookup
2670472	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
13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac74f96-3910-44b9-8551-036880fbb1fb	Product name	1	20260108
0a18eae4-4259-42db-86b6-915f66e83b06	Product name	1	20250729
2c999b01-2a13-4eff-8eb4-00b87316ef79	Product name	1	20231116
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
05193eb6-d122-ab0b-603b-d9dd92599836	Product name	2	20210204
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
2e5437ef-ff80-c9c2-2f66-5b7c771080be	Product name	9	20180201
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
ae28a785-50d8-477d-a268-dffdfdd7504b	Product name	1	20150305
0c878822-66ca-456d-c17d-0894b04fa473	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72990-103-03	DEFENCATH	3 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	3		7
72990-103-10	DEFENCATH	10 in 1 CARTON	SOLUTION	10		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72990-103-03	ML - Milliliter	72990-103	17232ee0-6950-42d6-b633-d1c0862b4176	1	2024-02-14
72990-103-10	ML - Milliliter	72990-103	8487ef94-f0e9-4bd3-92d8-bdfa38a02c41	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72990-103	DEFENCATH (TAUROLIDINE AND HEPARIN) SOLUTION [CORMEDIX INC.]	6	Current NDC, 2 package rows	20241228_13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6.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
DEFENCATH	TAUROLIDINE AND HEPARIN	CorMedix Inc.	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214520 application number: NDA214520 ndc (package): 72990-103-10 ndc (product): 72990-103 ndc11 (package): 72990010310

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8OBZ1M4V3V	TAUROLIDINE	19388-87-5	TAUROLIDINE
T2410KM04A	HEPARIN	9005-49-6	HEPARIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2670468	DEFENCATH 3000 UNT / 40.5 MG in 3 ML Injection	PSN	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670472	DEFENCATH 5000 UNT / 67.5 MG in 5 ML Injection	PSN	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670461	heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG in 3 ML Injection	PSN	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670471	heparin sodium, porcine 5,000 UNT / taurolidine 67.5 MG in 5 ML Injection	PSN	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670468	3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection [Defencath]	SBD	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670472	5 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection [Defencath]	SBD	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670461	3 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection	SCD	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670471	5 ML heparin sodium, porcine 1000 UNT/ML / taurolidine 13.5 MG/ML Injection	SCD	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670468	Defencath (heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG) per 3 ML Injection	SY	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670472	Defencath (heparin sodium, porcine 5,000 UNT / taurolidine 67.5 MG) per 5 ML Injection	SY	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670461	heparin sodium, porcine 3,000 UNT / taurolidine 40.5 MG per 3 ML Injection	SY	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7
2670471	heparin sodium, porcine 5,000 UNT / taurolidine 67.5 MG per 5 ML Injection	SY	13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72990-103-10	72990010310	10 VIAL, SINGLE-DOSE in 1 CARTON (72990-103-10) / 3 mL in 1 VIAL, SINGLE-DOSE (72990-103-03)	2024-04-09	No	No	Current