Allopurinol

Product NDC: 48433-002
Requested package NDC: 48433-002-20
11-digit product format: 484330002
Labeler code: 48433
Product ID: 48433-002_4e66e3c1-8729-eae1-e063-6294a90ac4bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA018659
Marketing category: ANDA
Marketing start: 2026-03-19
Substance: ALLOPURINOL
Active strength: 100 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	A018659-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	1986-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A018659-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	1986-10-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A018659-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A018659-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Allopurinol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	100 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197319	Internal RxNorm lookup
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
dbfb3bde-2274-43cc-b726-d4578ebdb5d4	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
48433-002-01	Allopurinol	1 in 1 BLISTER PACK	TABLET	1		2
48433-002-20	Allopurinol	100 in 1 CARTON	TABLET	100		2

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
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 ndc (package): 48433-002-20 ndc (product): 48433-002 ndc11 (package): 48433000220
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
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
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
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

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
197319	allopurinol 100 MG Oral Tablet	PSN	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2
197320	allopurinol 300 MG Oral Tablet	PSN	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2
197319	allopurinol 100 MG Oral Tablet	SCD	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2
197320	allopurinol 300 MG Oral Tablet	SCD	dbfb3bde-2274-43cc-b726-d4578ebdb5d4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-002-20	48433000220	100 BLISTER PACK in 1 CARTON (48433-002-20) / 1 TABLET in 1 BLISTER PACK (48433-002-01)	100 blister pack	2026-03-19	No	No	Current