Tiopronin

Product NDC: 44523-054
11-digit product format: 445230054
Labeler code: 44523
Product ID: 44523-054_36d7fad3-57c6-67e7-e063-6294a90ad7b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tiopronin
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: BioComp Pharma, Inc.
Application: NDA211843
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2024-12-05
Substance: TIOPRONIN
Active strength: 100 mg/1
Pharmacologic classes: Cystine Disulfide Reduction [MoA], N-substituted Glycines [CS], Reducing and Complexing Thiol [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N211843-001	THIOLA EC	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28
N211843-002	THIOLA EC	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N211843-001	AB
N211843-002	AB

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
N211843-001	11458104	2038-11-14	U-3441		2022-10-06
N211843-002	11458104	2038-11-14	U-3441		2022-10-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211843-001	ODE*	2026-06-28
N211843-002	ODE*	2026-06-28

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 3 · 84 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	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211843-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211843-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211843-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-002	AB	1	`9b2671bbb829…`
2023-05-13 08:27 UTC	2023-05	N211843-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211843-002	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211843-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`9b2671bbb829…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	ODE*	2026-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	ODE*	2026-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	ODE*	2026-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	ODE*	2026-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	ODE*	2026-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	ODE*	2026-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	ODE*	2026-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	ODE*	2026-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	ODE*	2026-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	ODE*	2026-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	ODE*	2026-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	ODE*	2026-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	ODE*	2026-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	ODE*	2026-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	ODE*	2026-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	ODE*	2026-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	ODE*	2026-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	ODE*	2026-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	ODE*	2026-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	ODE*	2026-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	ODE*	2026-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	ODE*	2026-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	ODE*	2026-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	ODE*	2026-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	ODE*	2026-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	ODE*	2026-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	ODE*	2026-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	ODE*	2026-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	ODE*	2026-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	ODE*	2026-06-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-001	ODE*	2026-06-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-002	ODE*	2026-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211843-001	ODE*	2026-06-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211843-002	ODE*	2026-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211843-001	ODE*	2026-06-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211843-002	ODE*	2026-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-001	ODE*	2026-06-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-002	ODE*	2026-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-001	ODE*	2026-06-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-002	ODE*	2026-06-28	`9b2671bbb829…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIOPRONIN	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C5W04GO61S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2178075	Internal RxNorm lookup
2178079	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
1f2eb1d6-faa6-e352-e063-6294a90a7fb5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
19fd197c-a0a2-47ec-a473-bf965abd1795	Product name	2	20250429
a6c2b4b8-5194-92f1-e438-706fc5c2e8b4	Product name	3	20230303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44523-054-01	Tiopronin	300 in 1 BOTTLE	TABLET, DELAYED RELEASE	300		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44523-054-01	EA - Each	44523-054	43d2916a-ad9a-4f7f-9320-62da9eeb0930	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44523-054	TIOPRONIN TABLET, DELAYED RELEASE [BIO COMP PHARMA, INC.]	1	Current NDC, 1 package rows	20241208_1f2eb1d6-faa6-e352-e063-6294a90a7fb5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thiola EC	TIOPRONIN	Mission Pharmacal Company	20298a52-a194-a161-8632-d84b6f26e23c	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211843 application number: NDA211843
Tiopronin	TIOPRONIN	BioComp Pharma, Inc.	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211843 application number: NDA211843 ndc (product): 44523-054

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C5W04GO61S	TIOPRONIN	1953-02-2	TIOPRONIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2178075	tiopronin 100 MG Delayed Release Oral Tablet	PSN	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2
2178079	tiopronin 300 MG Delayed Release Oral Tablet	PSN	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2
2178075	tiopronin 100 MG Delayed Release Oral Tablet	SCD	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2
2178079	tiopronin 300 MG Delayed Release Oral Tablet	SCD	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
44523-054-01	44523005401	300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01)	2024-12-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tiopronin	BioComp Pharma, Inc. \| Mission Pharmacal Company	2025-06-05	HUMAN PRESCRIPTION DRUG LABEL	2