Phenoxybenzamine Hydrochloride

Product NDC
70954-365
11-digit product format
709540365
Labeler code
70954
Product ID
70954-365_235c3c98-4dc2-4b5e-8bdc-f21d18cbb7ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenoxybenzamine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novitium Pharma LLC
Application
ANDA215042
Marketing category
ANDA
Marketing start
2022-07-19
Substance
PHENOXYBENZAMINE HYDROCHLORIDE
Active strength
10 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
Phenoxybenzamine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOXYBENZAMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX1IEG24OHL
Rxcui861402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
805d9e5d-594b-7d44-2033-963b5e3698baProduct name520240723
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-365-10Phenoxybenzamine Hydrochloride100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-365-10EA - Each70954-36518acc4d7-5c68-474d-8997-6ff1d606944112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-365PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC]2Current NDC, Legacy NDC, 1 package rows20221020_2cb5fcd7-c37f-41de-8beb-0c7eded9ed04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861402phenoxybenzamine HCl 10 MG Oral CapsulePSN2cb5fcd7-c37f-41de-8beb-0c7eded9ed042
861402phenoxybenzamine hydrochloride 10 MG Oral CapsuleSCD2cb5fcd7-c37f-41de-8beb-0c7eded9ed042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-365-1070954036510100 CAPSULE in 1 BOTTLE (70954-365-10) 100 capsule2022-07-190000-00-00NoNoCurrent