Home NDC 70954-365 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215042-001 PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2022-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215042-001 AB
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A215042-001 PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE / ORAL AB 2022-07-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A215042-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Phenoxybenzamine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOXYBENZAMINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X1IEG24OHL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861402 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-365-10 Phenoxybenzamine Hydrochloride 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-365 PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC] 2 Current NDC, Legacy NDC, 1 package rows 20221020_2cb5fcd7-c37f-41de-8beb-0c7eded9ed04.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70954-365-10 70954036510 100 CAPSULE in 1 BOTTLE (70954-365-10) 100 capsule 2022-07-19 0000-00-00 No No Current