ALLOPURINOL

Product NDC: 68788-4027
11-digit product format: 687884027
Labeler code: 68788
Product ID: 68788-4027_d83fec65-396a-40bd-8ee8-828d8930ea41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALLOPURINOL
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA217748
Marketing category: ANDA
Marketing start: 2025-09-22
Substance: ALLOPURINOL
Active strength: 100 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 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
A217748-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2023-08-03
A217748-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		2023-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217748-001	AB
A217748-002	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.

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	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217748-001	ALLOPURINOL	100MG	TABLET / ORAL	AB	2023-08-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217748-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	2023-08-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217748-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217748-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217748-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217748-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217748-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217748-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217748-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217748-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217748-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217748-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217748-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217748-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217748-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217748-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217748-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217748-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217748-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217748-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217748-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217748-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217748-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217748-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217748-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217748-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217748-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217748-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217748-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217748-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217748-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217748-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217748-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217748-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217748-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217748-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217748-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217748-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217748-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217748-002	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217748-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217748-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197319	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
d83fec65-396a-40bd-8ee8-828d8930ea41	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	SPL version
68788-4027-1	ALLOPURINOL	100 in 1 BOTTLE	TABLET	100	1
68788-4027-3	ALLOPURINOL	30 in 1 BOTTLE	TABLET	30	1
68788-4027-6	ALLOPURINOL	60 in 1 BOTTLE	TABLET	60	1
68788-4027-9	ALLOPURINOL	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-4027-1	EA - Each	68788-4027	a69925d1-e7b9-40b4-a862-9a5003003dec	1	2026-01-08
68788-4027-3	EA - Each	68788-4027	09334b4e-0e4d-4013-8408-64315fecfeb8	1	2026-01-08
68788-4027-6	EA - Each	68788-4027	57625931-e70f-43ce-ad4c-22fbbdaae198	1	2026-01-08
68788-4027-9	EA - Each	68788-4027	5fd214d1-c200-4c0d-a29c-9dbdde04a9ec	1	2026-01-08

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLOPURINOL	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	5644814c-3f61-5338-e063-6294a90ad6c9	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	Northwind Health Company, LLC	4deeebe3-fccc-2082-e063-6294a90a0c78	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	Bryant Ranch Prepack	d9961781-cfe8-459b-920d-eb000d45d41f	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	REMEDYREPACK INC.	20015399-43f8-4917-8ffe-dd8055c75712	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	XLCare Pharmaceuticals Inc.	fc7973c8-d846-4eca-ab0d-d30228035ba2	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	c476ae27-fa13-480c-8d02-58c2c2904b84	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	8047206e-305b-44d2-aa61-dff0366e7675	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
Allopurinol	ALLOPURINOL	Direct_Rx	426262e6-8219-c825-e063-6294a90a21a9	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	78978de2-1842-4570-9d11-67f13cc37ad5	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	A-S Medication Solutions	5955ca3f-9383-4025-ac58-90394716493a	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	Bryant Ranch Prepack	e453a5e0-44c3-4eb5-a8d0-7c02157d2f8c	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	Preferred Pharmaceuticals Inc.	d83fec65-396a-40bd-8ee8-828d8930ea41	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748 ndc (product): 68788-4027
ALLOPURINOL	ALLOPURINOL	Advanced Rx of Tennessee, LLC	36c1c908-1eed-ed2a-e063-6294a90a16f9	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	Preferred Pharmaceuticals Inc.	09d34fab-250c-496a-93f5-c8d9f52a2276	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
Allopurinol	ALLOPURINOL	A-S Medication Solutions	d9a20bf5-15b9-4643-b829-40eacd4e849d	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
Allopurinol	ALLOPURINOL	A-S Medication Solutions	869e09f7-fb72-4e15-8d4b-849e86ebc6fd	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748
ALLOPURINOL	ALLOPURINOL	Camber Pharmaceuticals, Inc.	60750373-7146-455a-8d12-d0e32d2d4bc8	2024-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217748 application number: ANDA217748

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	d83fec65-396a-40bd-8ee8-828d8930ea41	1
197319	allopurinol 100 MG Oral Tablet	SCD	d83fec65-396a-40bd-8ee8-828d8930ea41	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4027-1	68788402701	100 TABLET in 1 BOTTLE (68788-4027-1)	100 tablet	2025-09-22	No	No	Current
68788-4027-3	68788402703	30 TABLET in 1 BOTTLE (68788-4027-3)	30 tablet	2025-09-22	No	No	Current
68788-4027-6	68788402706	60 TABLET in 1 BOTTLE (68788-4027-6)	60 tablet	2025-09-22	No	No	Current
68788-4027-9	68788402709	90 TABLET in 1 BOTTLE (68788-4027-9)	90 tablet	2025-09-22	No	No	Current