OFIRMEV (ACETAMINOPHEN)

Product NDC
51662-1424
Requested package NDC
51662-1424-1
11-digit product format
516621424
Labeler code
51662
Product ID
51662-1424_9f34d89a-4c89-2e76-e053-2995a90aac7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OFIRMEV (ACETAMINOPHEN)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA022450
Marketing category
NDA
Marketing start
2019-12-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51662-142451662-1424-1IInactivated by FDA2026-08-17

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022450-001OFIRMEVACETAMINOPHEN1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022450-001103838342028-11-13U-22622019-09-18
N022450-001103838342028-11-13U-26212019-09-18
N022450-00196102652028-11-13U-22632017-05-04
N022450-00199872382028-11-13U-22612018-06-13
N022450-00110383834*PED2029-05-13Pediatric extension
N022450-0019610265*PED2029-05-13Pediatric extension
N022450-0019987238*PED2029-05-13Pediatric extension
N022450-00193990122031-09-11U-22612016-08-08
N022450-00193990122031-09-11U-22622016-08-08
N022450-0019399012*PED2032-03-11Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022450-001OFIRMEV1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD2010-11-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-023f01610625f2…
2019-09-15 20:21 UTC2019-09N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2010-11-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022450-001OFIRMEV1GM/100ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2010-11-02e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N022450-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022450-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022450-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022450-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N022450-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022450-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022450-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022450-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N022450-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022450-001AP1ea99ee380514…

Observed Orange Book patent history#

Patent history page 1 of 10 · 396 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N022450-001103838342028-11-13U-22622019-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N022450-001103838342028-11-13U-26212019-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07N022450-00196102652028-11-13U-22632017-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07N022450-00199872382028-11-13U-22612018-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N022450-00110383834*PED2029-05-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022450-0019610265*PED2029-05-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022450-0019987238*PED2029-05-13Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022450-00193990122031-09-11U-22622016-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07N022450-00193990122031-09-11U-22612016-08-08caaa826d4ba7…
2026-08-18 06:07:402026-07N022450-0019399012*PED2032-03-11Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022450-001103838342028-11-13U-22622019-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-001103838342028-11-13U-26212019-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-00196102652028-11-13U-22632017-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-00199872382028-11-13U-22612018-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-00110383834*PED2029-05-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-0019610265*PED2029-05-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-0019987238*PED2029-05-13Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-00193990122031-09-11U-22622016-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-00193990122031-09-11U-22612016-08-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022450-0019399012*PED2032-03-11Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-001103838342028-11-13U-22622019-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-001103838342028-11-13U-26212019-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-00196102652028-11-13U-22632017-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-00199872382028-11-13U-22612018-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-00110383834*PED2029-05-13Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-0019610265*PED2029-05-13Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-0019987238*PED2029-05-13Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-00193990122031-09-11U-22622016-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-00193990122031-09-11U-22612016-08-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022450-0019399012*PED2032-03-11Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022450-001103838342028-11-13U-22622019-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-001103838342028-11-13U-26212019-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-00196102652028-11-13U-22632017-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-00199872382028-11-13U-22612018-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-0019610265*PED2029-05-13Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-0019987238*PED2029-05-13Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-00193990122031-09-11U-22622016-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-00193990122031-09-11U-22612016-08-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022450-0019399012*PED2032-03-11Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022450-001103838342028-11-13U-22622019-09-18fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N022450-001M-1962020-01-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022450-001PED2020-07-2774a2ff9319b5…
2020-12-22 03:56 UTC2020-12N022450-001M-1962020-01-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022450-001PED2020-07-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022450-001M-1962020-01-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022450-001PED2020-07-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022450-001M-1962020-01-273f01610625f2…
2019-12-14 00:12 UTC2019-12N022450-001PED2020-07-273f01610625f2…
2019-09-15 20:21 UTC2019-09N022450-001M-1962020-01-27b00525d2431f…
2019-09-15 20:21 UTC2019-09N022450-001PED2020-07-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N022450-001M-1962020-01-27ea99ee380514…
2019-07-19 19:46 UTC2019-07N022450-001PED2020-07-27ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1424-12025-01-30C16284748780-12cef2736-a699-d83d-e063-dadaa90ab31fOFIRMEV (ACETAMINOPHEN) INJECTION 1000mg/100mL (10mg/mL) 100mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1424-1OFIRMEV (ACETAMINOPHEN)100 mL in 1 VIAL, GLASSINJECTION, SOLUTION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1424OFIRMEV (ACETAMINOPHEN) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Legacy NDC, 1 package rows20200223_9a38f63a-8852-6dab-e053-2a95a90a90d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483017acetaminophen 1000 MG in 100 ML InjectionPSN9a38f63a-8852-6dab-e053-2a95a90a90d62
483017100 ML acetaminophen 10 MG/ML InjectionSCD9a38f63a-8852-6dab-e053-2a95a90a90d62
483017100 ML APAP 10 MG/ML InjectionSY9a38f63a-8852-6dab-e053-2a95a90a90d62
483017acetaminophen 1000 MG per 100 ML InjectionSY9a38f63a-8852-6dab-e053-2a95a90a90d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1424-151662142401100 mL in 1 VIAL, GLASS (51662-1424-1) 100 ml2019-12-210000-00-00NoNoCurrent