Allopurinol

Product NDC: 55700-935
11-digit product format: 557000935
Labeler code: 55700
Product ID: 55700-935_46669e62-1d76-4467-beeb-633dad1093b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALLOPURINOL
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA203154
Marketing category: ANDA
Marketing start: 2021-09-09
Marketing end: 0000-00-00
Substance: ALLOPURINOL
Active strength: 300 mg/1
Pharmacologic classes: Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-935		D	Discontinued by firm		2026-08-17
excluded package	package	55700-935	55700-935-90	D	Discontinued by firm		2026-08-17

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 · 4 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-935-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-935-90	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203154-001	ALLOPURINOL	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06
A203154-002	ALLOPURINOL	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203154-001	AB
A203154-002	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 · 84 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	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB	RS	2013-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203154-001	ALLOPURINOL	100MG	TABLET / ORAL	AB		2013-05-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203154-002	ALLOPURINOL	300MG	TABLET / ORAL	AB		2013-05-06	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A203154-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203154-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203154-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203154-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203154-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203154-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203154-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203154-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203154-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203154-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203154-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203154-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203154-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203154-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203154-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203154-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203154-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203154-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203154-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203154-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203154-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203154-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203154-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203154-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203154-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203154-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203154-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203154-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203154-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-935-90	EA - Each	55700-935	555c4d03-55f6-4196-b872-8b23a57167be	1	2021-10-08

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	3bcd1381-34d9-4fa5-bfc5-2566cb7a7638	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Bryant Ranch Prepack	76ed9122-b845-423b-a6d5-a47b31743317	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Preferred Pharmaceuticals Inc.	eb1b1aa6-cbd3-4b06-b9f9-9a0779a2da08	2026-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Northwind Health Company, LLC	f3198e1b-6344-ad96-e053-2995a90a4aaf	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Accord Healthcare Inc.	682dd8b8-fc6e-47c5-95b7-82d7ad96b750	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Advanced Rx Pharmacy of Tennessee, LLC	ec09fbcf-6e20-8438-e053-2a95a90a6376	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	NuCare Pharmaceuticals, Inc.	44bcc8df-a803-010f-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	A-S Medication Solutions	71accbc4-8bd7-4d22-ae53-c7b044a15ffa	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Aphena Pharma Solutions - Tennessee, LLC	0155151c-6e84-4f9b-9233-60ffa7483293	2022-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154
Allopurinol	ALLOPURINOL	Proficient Rx LP	d94f6643-621f-45ed-b2dc-26f84c5626ae	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203154 application number: ANDA203154

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	Marketing end	Sample	Exclude flag	Status
55700-935-90	55700093590	90 TABLET in 1 BOTTLE (55700-935-90)	90 tablet	2021-09-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRODUCT INFORMATION Allopurinol Tablets USP 100 mg and 300 mg Tablets	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3