Allopurinol

Product NDC: 68071-2997
11-digit product format: 680712997
Labeler code: 68071
Product ID: 68071-2997_2d53e60e-6f9e-182d-e063-6294a90ab7f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA211820
Marketing category: ANDA
Marketing start: 2019-03-12
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

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 · 9 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
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2997-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2997-3	`302b2466d912…`	`e7b80fea0513…`
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	68071-2997-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2997-3	`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	68071-2997-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2997-3	`0efc9e666f02…`	`f202fb6c5f17…`

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
A211820-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12
A211820-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211820-001	AB
A211820-002	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	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2019-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211820-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2019-03-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211820-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2019-03-12	`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	A211820-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211820-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211820-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211820-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211820-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211820-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211820-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211820-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211820-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211820-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211820-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211820-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211820-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211820-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211820-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211820-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211820-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211820-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211820-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211820-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211820-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211820-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211820-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211820-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211820-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211820-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211820-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211820-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211820-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211820-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211820-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211820-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211820-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211820-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211820-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211820-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211820-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211820-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211820-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211820-002	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	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
faf55184-6962-d49f-e053-6394a90a152e	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-2997-3	2025-02-04	ALLOPURINOL tablets USP Rx Only
68071-2997-9	2025-02-04	ALLOPURINOL tablets USP Rx Only
68071-2997-3	2025-01-30	ALLOPURINOL tablets USP Rx Only
68071-2997-9	2025-01-30	ALLOPURINOL tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2997-3	Allopurinol	30 in 1 BOTTLE, PLASTIC	TABLET	30		3
68071-2997-9	Allopurinol	90 in 1 BOTTLE, PLASTIC	TABLET	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2997	ALLOPURINOL TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, 2 package rows	20250206_faf55184-6962-d49f-e053-6394a90a152e.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	36526c80-5a70-47c4-a0a6-785ccc346703	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	REMEDYREPACK INC.	5ffcbc32-5996-41cd-acdc-cc4af8cdaf4f	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	St. Mary's Medical Park Pharmacy	00b27899-e68f-e9d9-e063-6394a90a88cb	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	1f626471-153c-4740-8019-9089ea741684	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	8ae2d634-df53-40a8-a6bd-6fee7dacd754	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Direct_Rx	f6c83ee9-c07b-9fc8-e053-6394a90a2160	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	e11e94b9-d897-48ce-9a80-aa6b8b5fde02	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	Unichem Pharmaceuticals (USA), Inc.	e3face45-f920-46a0-b707-6a66aa9735bd	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	A-S Medication Solutions	5efa81be-e2c9-4fb7-bd0d-aeca3920a393	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	A-S Medication Solutions	f26674cd-d2b7-433c-a593-6a52012b81e3	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	American Health Packaging	f6f7642b-5046-47d6-b259-0c9f8aed3b34	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals,Inc.	faf55184-6962-d49f-e053-6394a90a152e	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820 ndc (product): 68071-2997
Allopurinol	ALLOPURINOL	A-S Medication Solutions	3db4e043-71ff-496a-8087-3fde0e352abf	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820
Allopurinol	ALLOPURINOL	A-S Medication Solutions	2caa5246-9422-4826-b926-a2566506d3eb	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211820 application number: ANDA211820

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	faf55184-6962-d49f-e053-6394a90a152e	3
197319	allopurinol 100 MG Oral Tablet	SCD	faf55184-6962-d49f-e053-6394a90a152e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-2997-3	68071299703	30 TABLET in 1 BOTTLE, PLASTIC (68071-2997-3)	30 tablet	2023-05-05	No	No	Current
68071-2997-9	68071299709	90 TABLET in 1 BOTTLE, PLASTIC (68071-2997-9)	90 tablet	2023-05-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALLOPURINOL tablets USP Rx Only	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	3