Allopurinol

Product NDC: 80425-0206
11-digit product format: 804250206
Labeler code: 80425
Product ID: 80425-0206_2a99b834-0c9d-6f97-e063-6394a90a8407
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA203154
Marketing category: ANDA
Marketing start: 2022-10-27
Substance: ALLOPURINOL
Active strength: 300 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase 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 43.

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
A203154-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06
A203154-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203154-001	AB
A203154-002	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2013-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A203154-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203154-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203154-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203154-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203154-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203154-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203154-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203154-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203154-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203154-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203154-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203154-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203154-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203154-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203154-002	AB	1	`74a2ff9319b5…`

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
Listing expiration: 2026-12-31

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
ec09fbcf-6e20-8438-e053-2a95a90a6376	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
80425-0206-1	Allopurinol	30 in 1 BOTTLE	TABLET	30		5
80425-0206-2	Allopurinol	60 in 1 BOTTLE	TABLET	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0206-1	EA - Each	80425-0206	36e9cd5b-3773-4ead-9c50-6f1144f44ec9	1	2023-03-13
80425-0206-2	EA - Each	80425-0206	265f1cc0-1b27-4ac5-936f-a3e93332177c	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0206	ALLOPURINOL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20250101_ec09fbcf-6e20-8438-e053-2a95a90a6376.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	3bcd1381-34d9-4fa5-bfc5-2566cb7a7638	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	76ed9122-b845-423b-a6d5-a47b31743317	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	eb1b1aa6-cbd3-4b06-b9f9-9a0779a2da08	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	f3198e1b-6344-ad96-e053-2995a90a4aaf	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Accord Healthcare Inc.	682dd8b8-fc6e-47c5-95b7-82d7ad96b750	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	ec09fbcf-6e20-8438-e053-2a95a90a6376	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154 ndc (product): 80425-0206
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	44bcc8df-a803-010f-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	A-S Medication Solutions	71accbc4-8bd7-4d22-ae53-c7b044a15ffa	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	0155151c-6e84-4f9b-9233-60ffa7483293	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Proficient Rx LP	d94f6643-621f-45ed-b2dc-26f84c5626ae	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154

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	ec09fbcf-6e20-8438-e053-2a95a90a6376	5
197320	allopurinol 300 MG Oral Tablet	SCD	ec09fbcf-6e20-8438-e053-2a95a90a6376	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0206-1	80425020601	30 TABLET in 1 BOTTLE (80425-0206-1)	30 tablet	2023-10-27	No	No	Current
80425-0206-2	80425020602	60 TABLET in 1 BOTTLE (80425-0206-2)	60 tablet	2023-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	5