PHENTOLAMINE MESYLATE

Product NDC
68094-101
11-digit product format
680940101
Labeler code
68094
Product ID
68094-101_4ecf4179-a773-4f75-a48b-a0b2c51facc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTOLAMINE MESYLATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Precision Dose Inc.
Application
ANDA207686
Marketing category
ANDA
Marketing start
2017-07-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENTOLAMINE MESYLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTOLAMINE MESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY7543E5K9T
Rxcui1361023

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
217cde05-1bd7-4d5d-bae5-725392a5286aProduct name120250623
52987bfd-5e19-a3f5-c33e-e68c5f75fe88Product name220170815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-101-10EA - Each68094-101259499bf-230d-4c6c-84a3-cbc5178147d212018-04-19
68094-101-20EA - Each68094-101aafd7854-6a35-4389-b521-f019a2aa143812018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-101PHENTOLAMINE MESYLATE INJECTION [PRECISION DOSE INC.]12Current NDC, Legacy NDC20240823_e146c7ee-d2fa-433c-8768-0945e4ff0990.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361023phentolamine mesylate 5 MG InjectionPSNe146c7ee-d2fa-433c-8768-0945e4ff099012
1361023phentolamine mesylate 5 MG InjectionSCDe146c7ee-d2fa-433c-8768-0945e4ff099012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-101-106809401011010 CARTON in 1 TRAY (68094-101-10) > 1 VIAL in 1 CARTON (68094-101-20) > 1 INJECTION in 1 VIAL10 carton2017-07-150000-00-00NoNoCurrent
68094-101-20680940101201 VIAL in 1 CARTON (68094-101-20) / 1 INJECTION in 1 VIAL1 vial2017-07-15NoNoHistorical