Allopurinol

Product NDC: 70518-4693
11-digit product format: 705184693
Labeler code: 70518
Product ID: 70518-4693_5691ea6c-70e7-6691-e063-6394a90a0880
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA204467
Marketing category: ANDA
Marketing start: 2026-07-07
Substance: ALLOPURINOL
Active strength: 300 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 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
Listing expiration: 2027-12-31

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
55280a8a-cf23-405b-b698-95a4d8e3c699	Available on FDA.report

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4693-0	70518469300	100 TABLET in 1 BOTTLE, PLASTIC (70518-4693-0)	100 tablet	2026-07-07	No	No	Current