Propylthiouracil

Product NDC: 67253-651
11-digit product format: 672530651
Labeler code: 67253
Product ID: 67253-651_99a1da9d-39dd-4fc1-8470-c486e5c8b850
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propylthiouracil
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA, Inc.
Application: NDA006188
Marketing category: NDA
Marketing start: 1947-07-28
Substance: PROPYLTHIOURACIL
Active strength: 50 mg/1
Pharmacologic classes: Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N006188-001	PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N006188-001	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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N006188-001	PROPYLTHIOURACIL	50MG	TABLET / ORAL	BD	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N006188-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N006188-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006188-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006188-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006188-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006188-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006188-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006188-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006188-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006188-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N006188-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006188-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006188-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006188-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N006188-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006188-001	BD	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N006188-001	BD	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N006188-001	BD	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N006188-001	BD	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N006188-001	BD	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N006188-001	BD	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N006188-001	BD	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N006188-001	BD	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N006188-001	BD	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N006188-001	BD	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N006188-001	BD	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N006188-001	BD	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N006188-001	BD	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N006188-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N006188-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N006188-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N006188-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N006188-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N006188-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N006188-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N006188-001	BD	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N006188-001	BD	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N006188-001	BD	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N006188-001	BD	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N006188-001	BD	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Propylthiouracil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPYLTHIOURACIL	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
721M9407IY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198175	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
b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5199f153-e97c-2898-8204-85c73892d5a5	Product name	2	20240513

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67253-651-10	2023-10-20	PROPYLTHIOURACIL TABLETS, USP
67253-651-11	2023-10-20	PROPYLTHIOURACIL TABLETS, USP
67253-651-10	2023-07-28	PROPYLTHIOURACIL TABLETS, USP
67253-651-11	2023-07-28	PROPYLTHIOURACIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67253-651-10	Propylthiouracil	100 in 1 BOTTLE	TABLET	100		17
67253-651-11	Propylthiouracil	1000 in 1 BOTTLE	TABLET	1000		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67253-651-10	EA - Each	67253-651	6d895d06-09a1-46ca-af5f-f5f7f9475bde	1	2014-05-02
67253-651-11	EA - Each	67253-651	be06e68e-2120-4a94-b48c-fe3f41c8faec	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPYLTHIOURACIL	ACTIVE INGREDIENT	721M9407IY	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
PROPYLTHIOURACIL	ACTIVE MOIETY	721M9407IY	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
SODIUM GLYCOLATE	INACTIVE INGREDIENT	B75E535IMI	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROPYLTHIOURACIL TABLET [DAVA PHARMACEUTICALS, INC.]	7
PROPYLTHIOURACIL	ACTIVE INGREDIENT	721M9407IY	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
PROPYLTHIOURACIL	ACTIVE MOIETY	721M9407IY	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM GLYCOLATE	INACTIVE INGREDIENT	B75E535IMI	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROPYLTHIOURACIL TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67253-651	PROPYLTHIOURACIL TABLET [ENDO USA, INC.]	17	Current NDC, Legacy NDC, 2 package rows	20250109_b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0.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
Propylthiouracil	PROPYLTHIOURACIL	Endo USA, Inc.	b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 006188 application number: NDA006188 ndc (product): 67253-651
Propylthiouracil	PROPYLTHIOURACIL	American Health Packaging	d819e532-09ac-434a-84a6-636c4204c7aa	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 006188 application number: NDA006188

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
721M9407IY	PROPYLTHIOURACIL	51-52-5	PROPYLTHIOURACIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198175	propylthiouracil 50 MG Oral Tablet	PSN	b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0	17
198175	propylthiouracil 50 MG Oral Tablet	SCD	b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0	17
198175	PTU 50 MG Oral Tablet	SY	b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0	17
198175	propylthiouracil 50 MG Oral Tablet	PSN	d819e532-09ac-434a-84a6-636c4204c7aa	6
198175	propylthiouracil 50 MG Oral Tablet	SCD	d819e532-09ac-434a-84a6-636c4204c7aa	6
198175	PTU 50 MG Oral Tablet	SY	d819e532-09ac-434a-84a6-636c4204c7aa	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67253-651-10	67253065110	100 TABLET in 1 BOTTLE (67253-651-10)	100 tablet	1947-07-28	0000-00-00	No	No	Current
67253-651-11	67253065111	1000 TABLET in 1 BOTTLE (67253-651-11)	1000 tablet	1947-07-28	2028-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPYLTHIOURACIL TABLETS, USP	Endo USA, Inc.	2024-11-22	HUMAN PRESCRIPTION DRUG LABEL	17
Propylthiouracil Tablets, USP Rx Only 8296421/0624F	American Health Packaging	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL	6