Thiola EC

Product NDC: 0178-0901
11-digit product format: 001780901
Labeler code: 0178
Product ID: 0178-0901_4098f871-874f-92ec-e063-6394a90af53f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tiopronin
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mission Pharmacal Company
Application: NDA211843
Marketing category: NDA
Marketing start: 2019-06-28
Substance: TIOPRONIN
Active strength: 300 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: Thiola EC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIOPRONIN	300 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2178075	Internal RxNorm lookup
2178077	Internal RxNorm lookup
2178079	Internal RxNorm lookup
2178081	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
20298a52-a194-a161-8632-d84b6f26e23c	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
0178-0901-90	Thiola EC	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0901-90	EA - Each	0178-0901	45b3f91d-bba2-4f47-96de-31af9693004b	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0901	THIOLA EC (TIOPRONIN) TABLET, DELAYED RELEASE [MISSION PHARMACAL COMPANY]	4	Current NDC, Legacy NDC, 1 package rows	20240110_20298a52-a194-a161-8632-d84b6f26e23c.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 ndc (product): 0178-0901
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

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
2178077	THIOLA EC 100 MG Delayed Release Oral Tablet	PSN	20298a52-a194-a161-8632-d84b6f26e23c	6
2178081	THIOLA EC 300 MG Delayed Release Oral Tablet	PSN	20298a52-a194-a161-8632-d84b6f26e23c	6
2178075	tiopronin 100 MG Delayed Release Oral Tablet	PSN	20298a52-a194-a161-8632-d84b6f26e23c	6
2178079	tiopronin 300 MG Delayed Release Oral Tablet	PSN	20298a52-a194-a161-8632-d84b6f26e23c	6
2178077	tiopronin 100 MG Delayed Release Oral Tablet [Thiola]	SBD	20298a52-a194-a161-8632-d84b6f26e23c	6
2178081	tiopronin 300 MG Delayed Release Oral Tablet [Thiola]	SBD	20298a52-a194-a161-8632-d84b6f26e23c	6
2178075	tiopronin 100 MG Delayed Release Oral Tablet	SCD	20298a52-a194-a161-8632-d84b6f26e23c	6
2178079	tiopronin 300 MG Delayed Release Oral Tablet	SCD	20298a52-a194-a161-8632-d84b6f26e23c	6
2178077	Thiola 100 MG Delayed Release Oral Tablet	SY	20298a52-a194-a161-8632-d84b6f26e23c	6
2178081	Thiola 300 MG Delayed Release Oral Tablet	SY	20298a52-a194-a161-8632-d84b6f26e23c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0178-0901-90	00178090190	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)	2019-06-28	0000-00-00	No	No	Current