ZYLOPRIM

Product NDC: 65483-993
11-digit product format: 654830993
Labeler code: 65483
Product ID: 65483-993_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: allopurinol
Dosage form: TABLET
Route: ORAL
Labeler: Prometheus Laboratories Inc.
Application: NDA016084
Marketing category: NDA
Marketing start: 1966-08-19
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65483-993		I	Inactivated by FDA	2026-08-07
excluded package	package	65483-993	65483-993-10	I	Inactivated by FDA	2026-08-07
excluded package	package	65483-993	65483-993-50	I	Inactivated by FDA	2026-08-07

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 2 · 66 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	65483-993-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65483-993-10	`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	65483-993-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65483-993-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65483-993-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65483-993-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65483-993-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65483-993-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65483-993-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65483-993-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65483-993-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65483-993-10	`cdf11ea48f46…`	`ba0047e9e063…`
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	65483-993-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65483-993-10	`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	65483-993-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65483-993-10	`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	65483-993-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65483-993-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65483-993-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65483-993-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65483-993-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65483-993-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65483-993-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65483-993-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65483-993-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65483-993-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65483-993-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65483-993-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65483-993-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65483-993-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65483-993-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65483-993-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65483-993-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65483-993-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65483-993-50	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65483-993-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65483-993-50	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65483-993-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65483-993-50	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65483-993-10	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 109 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-002	ZYLOPRIM	300MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-003	ZYLOPRIM	200MG	TABLET / ORAL		RLD	2022-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016084-001	ZYLOPRIM	100MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 95 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016084-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016084-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016084-002	AB	1	`8072bd15b7f6…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65483-993-10	2019-10-21	C162847	48780-1	956f9ecf-d69b-621f-e053-dbdaa90a74ad	PRODUCT INFORMATION ZYLOPRIM ® (allopurinol) 100-mg Scored Tablets and 300-mg Scored Tablets
65483-993-50	2019-10-21	C162847	48780-1	956f9ecf-d69b-621f-e053-dbdaa90a74ad	PRODUCT INFORMATION ZYLOPRIM ® (allopurinol) 100-mg Scored Tablets and 300-mg Scored Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65483-993-10	ZYLOPRIM	100 in 1 BOTTLE	TABLET	100		2
65483-993-50	ZYLOPRIM	500 in 1 BOTTLE	TABLET	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65483-993-10	EA - Each	65483-993	d5e8b099-7ff3-4d85-9539-4247a24e56b6	1	2012-07-24
65483-993-50	EA - Each	65483-993	5e82ec5e-c017-4b3b-84d2-bd554f059cf1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
allopurinol	ACTIVE INGREDIENT	63CZ7GJN5I	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
allopurinol	ACTIVE MOIETY	63CZ7GJN5I	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
povidone	INACTIVE INGREDIENT	FZ989GH94E	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2
starch, potato	INACTIVE INGREDIENT	8I089SAH3T	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65483-993	ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.]	2	Legacy NDC, 2 package rows	20091216_342832b5-1a32-4bea-bc49-ab0fd152154e.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
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	342832b5-1a32-4bea-bc49-ab0fd152154e	2
197320	allopurinol 300 MG Oral Tablet	PSN	342832b5-1a32-4bea-bc49-ab0fd152154e	2
213995	ZYLOPRIM 100 MG Oral Tablet	PSN	342832b5-1a32-4bea-bc49-ab0fd152154e	2
213998	ZYLOPRIM 300 MG Oral Tablet	PSN	342832b5-1a32-4bea-bc49-ab0fd152154e	2
213995	allopurinol 100 MG Oral Tablet [Zyloprim]	SBD	342832b5-1a32-4bea-bc49-ab0fd152154e	2
213998	allopurinol 300 MG Oral Tablet [Zyloprim]	SBD	342832b5-1a32-4bea-bc49-ab0fd152154e	2
197319	allopurinol 100 MG Oral Tablet	SCD	342832b5-1a32-4bea-bc49-ab0fd152154e	2
197320	allopurinol 300 MG Oral Tablet	SCD	342832b5-1a32-4bea-bc49-ab0fd152154e	2
213995	Zyloprim 100 MG Oral Tablet	SY	342832b5-1a32-4bea-bc49-ab0fd152154e	2
213998	Zyloprim 300 MG Oral Tablet	SY	342832b5-1a32-4bea-bc49-ab0fd152154e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65483-993-10	65483099310	100 in 1 BOTTLE	Historical
65483-993-50	65483099350	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRODUCT INFORMATION ZYLOPRIM ® (allopurinol) 100-mg Scored Tablets and 300-mg Scored Tablets	Prometheus Laboratories Inc. \| DSM Pharmaceuticals Inc.	2009-11-30	HUMAN PRESCRIPTION DRUG LABEL	2