TIOPRONIN

Product NDC: 0254-3035
11-digit product format: 002543035
Labeler code: 0254
Product ID: 0254-3035_44d74b79-7146-42ef-ace2-fa64cffeb041
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TIOPRONIN
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA217219
Marketing category: ANDA
Marketing start: 2024-06-26
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
A217219-001	TIOPRONIN	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-02-24
A217219-002	TIOPRONIN	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217219-001	AB
A217219-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217219-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217219-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-02-24	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217219-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217219-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217219-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217219-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217219-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217219-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217219-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217219-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217219-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217219-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217219-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217219-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217219-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217219-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217219-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217219-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217219-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217219-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217219-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217219-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217219-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217219-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217219-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217219-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217219-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217219-002	AB	1	`301d65b070ca…`
2023-05-13 08:27 UTC	2023-05	A217219-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A217219-002	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217219-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217219-002	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: TIOPRONIN
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 · 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
5396b9fd-5385-44fd-a8ba-e56a46a33bc7	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
0254-3035-09	TIOPRONIN	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0254-3035-09	EA - Each	0254-3035	f06cc0df-da65-480b-b5f2-0d6fd0d3f243	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0254-3035	TIOPRONIN TABLET, DELAYED RELEASE [ENDO USA, INC.]	7	Current NDC, 1 package rows	20250109_5396b9fd-5385-44fd-a8ba-e56a46a33bc7.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
TIOPRONIN	TIOPRONIN	Endo USA, Inc.	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	2022-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217219 application number: ANDA217219 ndc (product): 0254-3035

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	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	7
2178079	tiopronin 300 MG Delayed Release Oral Tablet	PSN	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	7
2178075	tiopronin 100 MG Delayed Release Oral Tablet	SCD	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	7
2178079	tiopronin 300 MG Delayed Release Oral Tablet	SCD	5396b9fd-5385-44fd-a8ba-e56a46a33bc7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0254-3035-09	00254303509	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3035-09)	2024-06-26	No	No	Current