FDA.reportPublic FDA data

Phenoxybenzamine Hydrochloride

Product NDC
66993-066
Requested package NDC
66993-066-02
11-digit product format
669930066
Labeler code
66993
Product ID
66993-066_171ac5e5-5222-46ed-b048-b750fa366b67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenoxybenzamine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA008708
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-08-11
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66993-06666993-066-02DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N008708-001DIBENZYLINEPHENOXYBENZAMINE HYDROCHLORIDE10MGCAPSULE / ORALRLD, Approved before 1982

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N008708-001DIBENZYLINE10MGCAPSULE / ORALRLD, Approved before 1982a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-066-02EA - Each66993-066fc1aa39c-6e47-4960-b027-89263a141e1712015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOXYBENZAMINE HYDROCHLORIDEACTIVE INGREDIENTX1IEG24OHLPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
PHENOXYBENZAMINEACTIVE MOIETY0TTZ664R7ZPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
GELATININACTIVE INGREDIENT2G86QN327LPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-066PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [PRASCO LABORATORIES]14Legacy NDC20230707_29ddb739-0f8e-4c41-ab4b-a6331ae2d508.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-066-0266993006602100 CAPSULE in 1 BOTTLE (66993-066-02) 100 capsule2015-08-110000-00-00NoNoCurrent