Antizol

Product NDC: 46129-200
11-digit product format: 461290200
Labeler code: 46129
Product ID: 46129-200_c045b5a8-b220-4f0a-a831-155b29c19454
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fomepizole
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: PALADIN LABORATORIES (USA) INC
Application: NDA020696
Marketing category: NDA
Marketing start: 2009-07-31
Marketing end: 0000-00-00
Substance: FOMEPIZOLE
Active strength: 1 g/mL
Pharmacologic classes: Antidote [EPC]
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	46129-200		I	Inactivated by FDA	2026-08-07
excluded package	package	46129-200	46129-200-01	I	Inactivated by FDA	2026-08-07
excluded package	package	46129-200	46129-200-02	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	46129-200-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46129-200-01	`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	46129-200-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46129-200-01	`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	46129-200-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46129-200-01	`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	46129-200-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46129-200-01	`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	46129-200-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46129-200-01	`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	46129-200-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46129-200-01	`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	46129-200-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46129-200-01	`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	46129-200-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46129-200-01	`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	46129-200-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46129-200-01	`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	46129-200-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46129-200-01	`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	46129-200-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	46129-200-01	`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	46129-200-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	46129-200-01	`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	46129-200-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	46129-200-01	`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	46129-200-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	46129-200-01	`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	46129-200-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	46129-200-01	`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	46129-200-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	46129-200-02	`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	46129-200-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	46129-200-02	`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	46129-200-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	46129-200-02	`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	46129-200-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	46129-200-02	`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	46129-200-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	46129-200-02	`e2bbac7714bc…`	`27bdfed8d636…`

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
N020696-001	ANTIZOL	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1997-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020696-001	7553863	2027-06-30		Drug substance, Drug product

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	RLD	1997-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020696-001	ANTIZOL	1.5GM/1.5ML (1GM/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1997-12-04	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020696-001	7553863	2027-06-30	Drug substance, Drug product	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
17cfe3bd-feab-64ba-c922-20d9bc250c81	Product name	2	20240809

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46129-200-01	2019-10-21	C162847	48780-1	956f9ecf-cef7-621f-e053-dbdaa90a74ad	c045b5a8-b220-4f0a-a831-155b29c19454
46129-200-02	2019-10-21	C162847	48780-1	956f9ecf-cef7-621f-e053-dbdaa90a74ad	c045b5a8-b220-4f0a-a831-155b29c19454

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46129-200-01	Antizol	1 in 1 PACKAGE	INJECTION	1	1
46129-200-01	Antizol	1.5 mL in 1 VIAL	INJECTION	1.5	1
46129-200-02	Antizol	1.5 mL in 1 VIAL	INJECTION	1.5	1
46129-200-02	Antizol	4 in 1 PACKAGE	INJECTION	4	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FOMEPIZOLE	ACTIVE INGREDIENT	83LCM6L2BY	ANTIZOL (FOMEPIZOLE) INJECTION [PALADIN LABORATORIES (USA) INC]	1
FOMEPIZOLE	ACTIVE MOIETY	83LCM6L2BY	ANTIZOL (FOMEPIZOLE) INJECTION [PALADIN LABORATORIES (USA) INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46129-200	ANTIZOL (FOMEPIZOLE) INJECTION [PALADIN LABORATORIES (USA) INC]	1	Legacy NDC, 4 package rows	20090813_c045b5a8-b220-4f0a-a831-155b29c19454.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83LCM6L2BY	FOMEPIZOLE	7554-65-6	FOMEPIZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
213184	ANTIZOL 1.5 GM in 1.5 ML Injection	PSN	c045b5a8-b220-4f0a-a831-155b29c19454	1
310414	fomepizole 1.5 GM in 1.5 ML Injection	PSN	c045b5a8-b220-4f0a-a831-155b29c19454	1
213184	1.5 ML fomepizole 1000 MG/ML Injection [Antizol]	SBD	c045b5a8-b220-4f0a-a831-155b29c19454	1
310414	1.5 ML fomepizole 1000 MG/ML Injection	SCD	c045b5a8-b220-4f0a-a831-155b29c19454	1
213184	1.5 ML Antizol 1000 MG/ML Injection	SY	c045b5a8-b220-4f0a-a831-155b29c19454	1
213184	Antizol 1.5 GM per 1.5 ML Injection	SY	c045b5a8-b220-4f0a-a831-155b29c19454	1
310414	fomepizole 1.5 GM per 1.5 ML Injection	SY	c045b5a8-b220-4f0a-a831-155b29c19454	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
46129-200-01	46129020001	1 in 1 PACKAGE		Historical
46129-200-02	46129020002	1.5 mL in 1 VIAL	1.5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antizol - PALADIN LABORATORIES (USA) INC \| Ben Venue Laboratories \| Ben Venue	PALADIN LABORATORIES (USA) INC \| Ben Venue Laboratories \| Ben Venue	2009-07-27	Human Prescription Drug Label	1