tiopronin

Product NDC: 60219-2009
11-digit product format: 602192009
Labeler code: 60219
Product ID: 60219-2009_98b9196d-4cc8-4ffe-8a45-8bced8f4284f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tiopronin
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA216278
Marketing category: ANDA
Marketing start: 2025-01-02
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
A216278-001	TIOPRONIN	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL			2023-08-15
A216278-002	TIOPRONIN	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL			2025-08-29

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216278-002	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2025-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216278-002	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2025-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216278-002	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2025-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-08-15	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216278-001	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL		2023-08-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216278-002	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL		2025-08-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216278-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216278-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216278-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216278-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216278-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216278-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216278-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216278-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216278-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216278-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216278-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216278-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216278-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216278-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216278-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216278-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216278-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216278-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216278-001	AB	1	`9b2671bbb829…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8	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
60219-2009-9	tiopronin	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-2009	TIOPRONIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]	6	Current NDC, 1 package rows	20230819_ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8.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	Amneal Pharmaceuticals NY LLC	ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216278 application number: ANDA216278 ndc (product): 60219-2009

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
2178079	tiopronin 300 MG Delayed Release Oral Tablet	PSN	ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8	8
2178079	tiopronin 300 MG Delayed Release Oral Tablet	SCD	ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60219-2009-9	60219200909	90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9)	2025-01-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tiopronin	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals of New York, LLC \| Amneal Pharmaceuticals Private Limited	2023-05-18	HUMAN PRESCRIPTION DRUG LABEL	6