Application 018659

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	100MG	No	No
002	ALLOPURINOL	ALLOPURINOL	TABLET;ORAL	300MG	No	No

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
A018659-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		1986-10-24
A018659-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		1986-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A018659-001	AB
A018659-002	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 3 · 84 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	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A018659-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A018659-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A018659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A018659-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A018659-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A018659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A018659-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A018659-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A018659-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A018659-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A018659-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A018659-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A018659-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A018659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A018659-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A018659-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A018659-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A018659-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A018659-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A018659-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A018659-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A018659-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A018659-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A018659-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A018659-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A018659-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A018659-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A018659-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A018659-002	AB	1	`bb7c543d1eb4…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	ced59048-c147-4702-af32-2f9b517ed87a	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Cardinal Health 107, LLC	1ce96b87-323d-40b6-a40b-32821e00d94c	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659 ndc (product): 55154-5454 ndc (product): 55154-5534
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	5dca2d4f-0e93-4d1a-8d9f-b9b72867c242	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Safecor Health, LLC	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	7c7eafa6-5411-470c-8a45-cfbc85d3e335	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Mylan Pharmaceuticals Inc.	bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659 ndc (product): 0378-0137 ndc (product): 0378-0181
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	8f50e91e-66a7-4fd4-888a-9f1986aa661c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Mylan Institutional Inc.	994b3117-b83e-44d9-910c-1c3a26ef838e	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659 ndc (product): 51079-206 ndc (product): 51079-205
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	15d758f9-2ec5-ecf5-e063-6394a90a7a2c	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Coupler LLC	65171cf0-8486-1ca6-e053-2991aa0ab91f	2018-04-18		Exact identifier application applno (ANDA): 018659 application number: ANDA018659
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	aea483a7-4ce7-4fe5-936c-fd876b4fa3a8	2017-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659 ndc (product): 43353-186
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	ae821c68-626a-474c-b81d-ce75d9795b3c	2016-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 018659 application number: ANDA018659 ndc (product): 67544-736

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0137	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0137	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0137	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0137	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0181	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0181	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0181	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0181	Allopurinol	allopurinol	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-1592	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1592	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1592	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1593	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1593	Allopurinol	Allopurinol	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-186	Allopurinol	allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-205	Allopurinol	allopurinol	Mylan Institutional Inc.	ANDA	Current
51079-205	Allopurinol	allopurinol	Mylan Institutional Inc.	ANDA	Current
51079-205	Allopurinol	allopurinol	Mylan Institutional Inc.	ANDA	Current
51079-206	Allopurinol	allopurinol	Mylan Institutional Inc.	ANDA	Current
51079-206	Allopurinol	allopurinol	Mylan Institutional Inc.	ANDA	Current
51079-206	Allopurinol	allopurinol	Mylan Institutional Inc.	ANDA	Current
55154-5454	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5454	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5454	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5454	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5454	Allopurinol	Allopurinol	Cardinal Health 107, LLC	ANDA	Current
55154-5454	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5534	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5534	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5534	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5534	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
55154-5534	Allopurinol	Allopurinol	Cardinal Health 107, LLC	ANDA	Current
55154-5534	Allopurinol	Allopurinol	Cardinal Health, Inc.	ANDA	Current
67046-681	Zyloprim	Allopurinol	Contract Pharmacy Services-PA	ANDA	Current
67544-736	Allopurinol	allopurinol	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68788-6422	Allopurinol	allopurinol	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1407	Allopurinol	allopurinol	REMEDYREPACK INC.	ANDA	Current
70518-1407	Allopurinol	allopurinol	REMEDYREPACK INC.	ANDA	Current