Allopurinol

Product NDC: 55111-729
Requested package NDC: 55111-729-01
11-digit product format: 551110729
Labeler code: 55111
Product ID: 55111-729_c3be239e-a0b5-fb8d-2ae6-372cef6fa362
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA071586
Marketing category: ANDA
Marketing start: 2009-10-01
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071586-001	LOPURIN	ALLOPURINOL	100MG	TABLET / ORAL	AB		1987-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071586-001	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 2 · 41 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	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071586-001	LOPURIN	100MG	TABLET / ORAL	AB	1987-04-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071586-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071586-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071586-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071586-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071586-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071586-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071586-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071586-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071586-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071586-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071586-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071586-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071586-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071586-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071586-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071586-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071586-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071586-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071586-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071586-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071586-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071586-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071586-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071586-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071586-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071586-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071586-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071586-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071586-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071586-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071586-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071586-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071586-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071586-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071586-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071586-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071586-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071586-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071586-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071586-001	AB	1	`cb3db0bc1861…`

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 · 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
19a138b8-d225-03e6-f762-abe71560204b	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
55111-729-01	Allopurinol	100 in 1 BOTTLE	TABLET	100		14
55111-729-10	Allopurinol	1000 in 1 BOTTLE	TABLET	1000		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-729-01	EA - Each	55111-729	f7fe4077-dc7c-4afe-a246-b78382577262	1	2012-07-24
55111-729-10	EA - Each	55111-729	db7de695-b720-4eae-bfdb-19e50d06c1f6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Allopurinol	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
Allopurinol	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
povidone	INACTIVE INGREDIENT	FZ989GH94E	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	9
Allopurinol	ACTIVE INGREDIENT	63CZ7GJN5I	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
Allopurinol	ACTIVE MOIETY	63CZ7GJN5I	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-729	ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]	12	Current NDC, Legacy NDC, 2 package rows	20241222_19a138b8-d225-03e6-f762-abe71560204b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	fe06da1b-c493-e238-e053-6294a90a9195	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586
Allopurinol	ALLOPURINOL	Dr. Reddy's Laboratories Limited	19a138b8-d225-03e6-f762-abe71560204b	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586 ndc (package): 55111-729-01 ndc (product): 55111-729 ndc11 (package): 55111072901
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	5a1bfae2-116f-4ef9-bb7b-3b69ac74df03	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	3dc4980c-8062-4239-a860-63888cabee46	2021-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071586 application number: ANDA071586

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	19a138b8-d225-03e6-f762-abe71560204b	14
197320	allopurinol 300 MG Oral Tablet	PSN	19a138b8-d225-03e6-f762-abe71560204b	14
197319	allopurinol 100 MG Oral Tablet	SCD	19a138b8-d225-03e6-f762-abe71560204b	14
197320	allopurinol 300 MG Oral Tablet	SCD	19a138b8-d225-03e6-f762-abe71560204b	14
197319	allopurinol 100 MG Oral Tablet	PSN	3dc4980c-8062-4239-a860-63888cabee46	3
197319	allopurinol 100 MG Oral Tablet	PSN	5a1bfae2-116f-4ef9-bb7b-3b69ac74df03	3
197319	allopurinol 100 MG Oral Tablet	PSN	fe06da1b-c493-e238-e053-6294a90a9195	3
197319	allopurinol 100 MG Oral Tablet	SCD	3dc4980c-8062-4239-a860-63888cabee46	3
197319	allopurinol 100 MG Oral Tablet	SCD	5a1bfae2-116f-4ef9-bb7b-3b69ac74df03	3
197319	allopurinol 100 MG Oral Tablet	SCD	fe06da1b-c493-e238-e053-6294a90a9195	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-729-01	55111072901	100 TABLET in 1 BOTTLE (55111-729-01)	100 tablet	2009-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Allopurinol	Dr. Reddy's Laboratories Limited	2025-09-09	HUMAN PRESCRIPTION DRUG LABEL	14
Allopurinol	Bryant Ranch Prepack	2025-01-30	HUMAN PRESCRIPTION DRUG LABEL	3
Allopurinol Tablets	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol Tablets	Aphena Pharma Solutions - Tennessee, LLC	2021-08-03	HUMAN PRESCRIPTION DRUG LABEL	3
Allopurinol Tablets	Quality Care Products, LLC	2020-08-26	HUMAN PRESCRIPTION DRUG LABEL	1
Allopurinol Tablets	Golden State Medical Supply, Inc.	2020-01-09	HUMAN PRESCRIPTION DRUG LABEL	3