Ofirmev

Product NDC: 43825-102
11-digit product format: 438250102
Labeler code: 43825
Product ID: 43825-102_c5662877-ba4e-4f2b-a64e-3ecab2358a53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Mallinckrodt Hospital Products Inc.
Application: NDA022450
Marketing category: NDA
Marketing start: 2010-11-08
Marketing end: 2022-07-31
Substance: ACETAMINOPHEN
Active strength: 10 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	43825-102		D	Discontinued by firm	2026-08-17
excluded package	package	43825-102	43825-102-01	D	Discontinued by firm	2026-08-17
excluded package	package	43825-102	43825-102-03	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 · 36 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	43825-102-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43825-102-03	`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	43825-102-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43825-102-03	`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	43825-102-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43825-102-03	`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	43825-102-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43825-102-03	`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	43825-102-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43825-102-03	`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	43825-102-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43825-102-03	`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	43825-102-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43825-102-03	`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	43825-102-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43825-102-03	`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	43825-102-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43825-102-03	`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	43825-102-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43825-102-03	`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	43825-102-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43825-102-03	`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	43825-102-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43825-102-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
N022450-001	OFIRMEV	ACETAMINOPHEN	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022450-001	10383834	2028-11-13	U-2262		2019-09-18
N022450-001	10383834	2028-11-13	U-2621		2019-09-18
N022450-001	9610265	2028-11-13	U-2263		2017-05-04
N022450-001	9987238	2028-11-13	U-2261		2018-06-13
N022450-001	10383834*PED	2029-05-13		Pediatric extension
N022450-001	9610265*PED	2029-05-13		Pediatric extension
N022450-001	9987238*PED	2029-05-13		Pediatric extension
N022450-001	9399012	2031-09-11	U-2261		2016-08-08
N022450-001	9399012	2031-09-11	U-2262		2016-08-08
N022450-001	9399012*PED	2032-03-11		Pediatric extension

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 · 42 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	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022450-001	OFIRMEV	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2010-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022450-001	OFIRMEV	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD	2010-11-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022450-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022450-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022450-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022450-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022450-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022450-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022450-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022450-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022450-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022450-001	AP	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	10383834*PED	2029-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	10383834	2028-11-13	U-2621		2019-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9610265	2028-11-13	U-2263		2017-05-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9987238	2028-11-13	U-2261		2018-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9610265*PED	2029-05-13		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9987238*PED	2029-05-13		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9399012	2031-09-11	U-2262		2016-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9399012	2031-09-11	U-2261		2016-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022450-001	9399012*PED	2032-03-11		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022450-001	10383834	2028-11-13	U-2262		2019-09-18	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022450-001	M-196	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022450-001	PED	2020-07-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022450-001	M-196	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022450-001	PED	2020-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022450-001	M-196	2020-01-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022450-001	PED	2020-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022450-001	M-196	2020-01-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022450-001	PED	2020-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022450-001	M-196	2020-01-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022450-001	PED	2020-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022450-001	M-196	2020-01-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022450-001	PED	2020-07-27	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43825-102-01	ML - Milliliter	43825-102	2070b17e-60cd-4fb0-b5fe-aec04084d4d3	1	2012-07-24
43825-102-03	ML - Milliliter	43825-102	2757a0a6-9011-4200-893f-f5d5d492fef6	1	2019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
CYSTEINE HYDROCHLORIDE	INACTIVE INGREDIENT	ZT934N0X4W	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
NITROGEN	INACTIVE INGREDIENT	N762921K75	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]	11

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483017	acetaminophen 1000 MG in 100 ML Injection	PSN	9a38f63a-8852-6dab-e053-2a95a90a90d6	2
483017	100 ML acetaminophen 10 MG/ML Injection	SCD	9a38f63a-8852-6dab-e053-2a95a90a90d6	2
483017	100 ML APAP 10 MG/ML Injection	SY	9a38f63a-8852-6dab-e053-2a95a90a90d6	2
483017	acetaminophen 1000 MG per 100 ML Injection	SY	9a38f63a-8852-6dab-e053-2a95a90a90d6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43825-102-01	43825010201	24 VIAL, GLASS in 1 CARTON (43825-102-01) > 100 mL in 1 VIAL, GLASS		2010-11-08	0000-00-00	No	No	Current
43825-102-03	43825010203	24 BAG in 1 CARTON (43825-102-03) > 100 mL in 1 BAG	24 bag	2017-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ofirmev	Mallinckrodt Hospital Products Inc. \| Catalent Anagni S.R.L. \| SpecGx LLC \| Fresenius Kabi Norge AS	2021-12-07	HUMAN PRESCRIPTION DRUG LABEL	21
OFIRMEV (ACETAMINOPHEN) INJECTION 1000mg/100mL (10mg/mL) 100mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2020-02-22	HUMAN PRESCRIPTION DRUG LABEL	2