TIOPRONIN

Product NDC: 13668-692
11-digit product format: 136680692
Labeler code: 13668
Product ID: 13668-692_b56545da-a8ae-437a-9757-44862a6d95f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tiopronin
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA216990
Marketing category: ANDA
Marketing start: 2024-01-30
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 1.

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
A216990-001	VENXXIVA	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB		2024-01-30
A216990-002	VENXXIVA	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB		2024-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216990-001	AB
A216990-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216990-001	VENXXIVA	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216990-002	VENXXIVA	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216990-001	VENXXIVA	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216990-002	VENXXIVA	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216990-001	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216990-002	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216990-001	VENXXIVA	100MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216990-002	VENXXIVA	300MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-01-30	`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	A216990-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216990-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216990-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216990-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216990-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216990-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216990-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216990-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216990-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216990-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216990-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216990-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216990-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216990-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216990-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216990-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216990-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216990-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216990-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216990-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216990-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216990-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216990-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216990-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216990-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216990-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216990-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216990-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216990-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216990-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216990-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216990-002	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216990-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216990-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
VENXXIVA	TIOPRONIN	Cycle Pharmaceuticals Ltd.	02e24443-04c6-4b98-a395-49aec4a468de	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216990 application number: ANDA216990
TIOPRONIN	TIOPRONIN	Torrent Pharmaceuticals Limited	ad750031-08ec-4d92-af2d-97a80c454e14	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216990 application number: ANDA216990 ndc (product): 13668-692

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
ad750031-08ec-4d92-af2d-97a80c454e14	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
13668-692-90	TIOPRONIN	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-692-90	EA - Each	13668-692	125f20c3-efc7-4dcb-823e-96292448862a	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-692	TIOPRONIN TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	2	Current NDC, 1 package rows	20241103_ad750031-08ec-4d92-af2d-97a80c454e14.zip

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	ad750031-08ec-4d92-af2d-97a80c454e14	2
2178079	tiopronin 300 MG Delayed Release Oral Tablet	PSN	ad750031-08ec-4d92-af2d-97a80c454e14	2
2178075	tiopronin 100 MG Delayed Release Oral Tablet	SCD	ad750031-08ec-4d92-af2d-97a80c454e14	2
2178079	tiopronin 300 MG Delayed Release Oral Tablet	SCD	ad750031-08ec-4d92-af2d-97a80c454e14	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
13668-692-90	13668069290	90 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-692-90)	2024-01-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIOPRONIN	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc. \| Optimus Pharma Private Limited	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	2