OFIRMEV (ACETAMINOPHEN)

Product NDC
51662-1424
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

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