FDA.reportPublic FDA data

Dibenzyline

Product NDC
59212-001
11-digit product format
592120001
Labeler code
59212
Product ID
59212-001_4580dfa2-961f-4953-ae7e-e0b7d9db1224
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenoxybenzamine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Concordia Pharmaceuticals Inc.
Application
NDA008708
Marketing category
NDA
Marketing start
1953-01-26
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
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59212-001DDiscontinued by firm2026-07-31
excluded packagepackage59212-00159212-001-01DDiscontinued by firm2026-07-31
excluded packagepackage59212-00159212-001-02DDiscontinued 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
59212-001-01EA - Each59212-001e047dac1-8d0c-4d49-b4d0-6247a4ca8f8612016-02-04
59212-001-02EA - Each59212-001da424fd2-5aa3-4387-856c-978695fa658a12021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOXYBENZAMINE HYDROCHLORIDEACTIVE INGREDIENTX1IEG24OHLDIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1
PHENOXYBENZAMINEACTIVE MOIETY0TTZ664R7ZDIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [CONCORDIA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-001DIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [ADVANZ PHARMA (US) CORP.]10Legacy NDC20241210_8852dd44-098c-4d99-88e0-a092a8e08e11.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-001-0159212000101100 CAPSULE in 1 BOTTLE (59212-001-01) 100 capsule1953-01-260000-00-00NoNoCurrent
59212-001-0259212000102100 CAPSULE in 1 BOTTLE (59212-001-02) 100 capsule2020-09-010000-00-00NoNoCurrent