Tiopronin

Product NDC: 0093-7909
Requested package NDC: 0093-7909-00
11-digit product format: 000937909
Labeler code: 0093
Product ID: 0093-7909_f2fc3b85-ad95-4e79-b523-5dab8ff96c96
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tiopronin
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA214326
Marketing category: ANDA
Marketing start: 2021-05-17
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0093-7909	0093-7909-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214326-001	TIOPRONIN	TIOPRONIN	100MG	TABLET / ORAL	AB		2021-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214326-001	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	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214326-001	TIOPRONIN	100MG	TABLET / ORAL	AB	2021-04-26	`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	A214326-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214326-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214326-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214326-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214326-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214326-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214326-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214326-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214326-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214326-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214326-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214326-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214326-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214326-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214326-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214326-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214326-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214326-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214326-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214326-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214326-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214326-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214326-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214326-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214326-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214326-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214326-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214326-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214326-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214326-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214326-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214326-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214326-001	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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198287	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
8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
a6c2b4b8-5194-92f1-e438-706fc5c2e8b4	Product name	3	20230303
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-7909-01	Tiopronin	100 in 1 BOTTLE	TABLET, SUGAR COATED	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7909-01	EA - Each	0093-7909	68a8b040-ab4f-4911-a505-31a5196c2ec8	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7909	TIOPRONIN TABLET, SUGAR COATED [TEVA PHARMACEUTICALS USA, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250416_8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9.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	Teva Pharmaceuticals USA, Inc.	8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214326 application number: ANDA214326 ndc (product): 0093-7909

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
198287	tiopronin 100 MG Oral Tablet	PSN	8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9	4
198287	tiopronin 100 MG Oral Tablet	SCD	8dee6eff-0ec1-4fe7-8d27-18cdc6cf54b9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
0093-7909-00	00093790900	27778 TABLET, SUGAR COATED in 1 BOX (0093-7909-00)	02-JUL-21	Current