ALLOPURINOL

Product NDC: 72189-417
11-digit product format: 721890417
Labeler code: 72189
Product ID: 72189-417_4c4bb472-bcf4-c5df-e063-6394a90a787d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALLOPURINOL
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA204467
Marketing category: ANDA
Marketing start: 2023-02-02
Marketing end: 2029-10-31
Substance: ALLOPURINOL
Active strength: 300 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-417-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-417-90	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204467-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28
A204467-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28
A204467-003	ALLOPURINOL	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204467-001	AB
A204467-002	AB
A204467-003	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 · 92 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
2026-09-14 22:38:34	2026-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-003	ALLOPURINOL	200MG	TABLET / ORAL	AB	2025-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2016-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204467-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2016-07-28	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204467-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204467-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204467-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204467-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204467-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204467-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204467-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204467-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204467-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204467-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204467-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204467-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204467-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204467-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204467-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204467-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204467-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204467-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204467-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204467-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204467-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204467-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204467-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204467-001	AB	1	`5d02ea3f76ae…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ALLOPURINOL

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63CZ7GJN5I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197320	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
f3bd5852-8e43-6b5d-e053-2995a90a194f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ee55bab-4ea8-ac26-c688-380cfbcd5c03	Product name	7	20260127
de89a493-168f-43fa-9852-1f15e00dbb17	Product name	1	20221110
4a2a34d6-1853-423b-9e0c-360370b95802	Product name	1	20171006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-417-30	ALLOPURINOL	30 in 1 BOTTLE	TABLET	30		3
72189-417-90	ALLOPURINOL	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-417-90	EA - Each	72189-417	e6c70105-a888-43f4-8d63-623f94e4d4c0	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-417	ALLOPURINOL TABLET [DIRECT_RX]	2	Current NDC, 2 package rows	20250123_f3bd5852-8e43-6b5d-e053-2995a90a194f.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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	NorthStar RxLLC	95a1ca8c-9855-4b11-92cd-6fdc144f0d3b	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	1b1c5cde-b2ed-ebc8-e063-6394a90a66c6	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	7bf1be4e-72ba-407c-90b3-b70b09a25d6e	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	11f1fc6e-b274-4132-9edd-522a819a479b	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	A-S Medication Solutions	420d338d-4d0d-4e38-bfe2-a83256821b45	2024-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	a5c35283-09d2-4bb4-bdd1-055035fa272b	2022-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	f99f4637-4d67-4b3c-8741-b775a9d0bde1	2022-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204467 application number: ANDA204467

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
63CZ7GJN5I	ALLOPURINOL	315-30-0	ALLOPURINOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197320	allopurinol 300 MG Oral Tablet	PSN	f3bd5852-8e43-6b5d-e053-2995a90a194f	3
197320	allopurinol 300 MG Oral Tablet	SCD	f3bd5852-8e43-6b5d-e053-2995a90a194f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-417-30	72189041730	30 TABLET in 1 BOTTLE (72189-417-30)	30 tablet	2023-02-02	2029-10-31	No	No	Historical
72189-417-90	72189041790	90 TABLET in 1 BOTTLE (72189-417-90)	90 tablet	2023-02-02	2029-10-31	No	No	Historical