Phentolamine Mesylate

Product NDC
51224-012
11-digit product format
512240012
Labeler code
51224
Product ID
51224-012_f70b960c-7d8d-4b87-8b5a-57cbcda74af0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentolamine Mesylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
TAGI Pharma, Inc.
Application
ANDA207686
Marketing category
ANDA
Marketing start
2017-07-15
Marketing end
0000-00-00
Substance
PHENTOLAMINE MESYLATE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-012-10EA - Each51224-0124848349d-866c-4ebf-b88a-d68c6b935e2212018-04-19
51224-012-20EA - Each51224-012c70f54fa-0464-41a2-84a5-d5f5d888375c12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-012PHENTOLAMINE MESYLATE INJECTION [TAGI PHARMA, INC.]7Legacy NDC20250503_fe1e10f5-4ff3-4616-9534-489648d88d33.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-012-105122400121010 CARTON in 1 TRAY (51224-012-10) > 1 VIAL in 1 CARTON (51224-012-20) > 1 INJECTION in 1 VIAL10 carton2017-07-150000-00-00NoNoCurrent