Allopurinol

Product NDC: 16571-884
11-digit product format: 165710884
Labeler code: 16571
Product ID: 16571-884_5cd32f4f-2795-4776-ad00-f33f91bda391
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: NDA016084
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-09-21
Substance: ALLOPURINOL
Active strength: 200 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 42.

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	RLD / RS	Approval date
N016084-001	ZYLOPRIM	ALLOPURINOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982
N016084-002	ZYLOPRIM	ALLOPURINOL	300MG	TABLET / ORAL	AB	RLD, Approved before 1982
N016084-003	ZYLOPRIM	ALLOPURINOL	200MG	TABLET / ORAL	AB	RLD	2022-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N016084-001	AB
N016084-002	AB
N016084-003	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 · 112 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
2026-08-18 06:07:40	2026-07	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL	AB	RLD	2022-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016084-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016084-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016084-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016084-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016084-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016084-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016084-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016084-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016084-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016084-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016084-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016084-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016084-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016084-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016084-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016084-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016084-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALLOPURINOL	200 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197319	Internal RxNorm lookup
197320	Internal RxNorm lookup
245422	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
30ad5ba2-1cef-4933-b104-0597f6a2aaa2	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
16571-884-01	Allopurinol	100 in 1 BOTTLE	TABLET	100	4
16571-884-09	Allopurinol	90 in 1 BOTTLE	TABLET	90	4
16571-884-10	Allopurinol	1000 in 1 BOTTLE	TABLET	1000	4
16571-884-50	Allopurinol	500 in 1 BOTTLE	TABLET	500	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-884-09	EA - Each	16571-884	e73e0f85-dbb5-40a0-9e39-83d74fd5a0bf	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-884	ALLOPURINOL TABLET [RISING PHARMA HOLDINGS, INC.]	4	Current NDC, Legacy NDC, 4 package rows	20231219_30ad5ba2-1cef-4933-b104-0597f6a2aaa2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Rising Pharma Holdings, Inc.	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016084 application number: NDA016084 ndc (product): 16571-884
Allopurinol	ALLOPURINOL	Coupler LLC	2d6ce57f-a9df-319e-e063-6394a90ac93f	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016084 application number: NDA016084

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	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	4
245422	allopurinol 200 MG Oral Tablet	PSN	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	4
197320	allopurinol 300 MG Oral Tablet	PSN	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	4
197319	allopurinol 100 MG Oral Tablet	SCD	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	4
245422	allopurinol 200 MG Oral Tablet	SCD	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	4
197320	allopurinol 300 MG Oral Tablet	SCD	30ad5ba2-1cef-4933-b104-0597f6a2aaa2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-884-01	16571088401	100 TABLET in 1 BOTTLE (16571-884-01)	100 tablet	2023-09-21		No	No	Current
16571-884-09	16571088409	90 TABLET in 1 BOTTLE (16571-884-09)	90 tablet	2023-09-21	0000-00-00	No	No	Current
16571-884-10	16571088410	1000 TABLET in 1 BOTTLE (16571-884-10)	1000 tablet	2023-09-21		No	No	Current
16571-884-50	16571088450	500 TABLET in 1 BOTTLE (16571-884-50)	500 tablet	2023-09-21		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Allopurinol	Rising Pharma Holdings, Inc. \| Cohance Lifesciences Limited	2026-05-21	Human Prescription Drug Label	5