Home NDC 0054-0349-25 Phenoxybenzamine Hydrochloride
Product NDC 0054-0349
Requested package NDC 0054-0349-25
11-digit product format 000540349
Labeler code 0054
Product ID 0054-0349_ccfdacba-c4d3-4977-8a7e-c265d0fe277a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenoxybenzamine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA201050
Marketing category ANDA
Marketing start 2015-08-10
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 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 A201050-001 PHENOXYBENZAMINE HYDROCHLORIDE PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE / ORAL 2012-07-16
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 A201050-001 PHENOXYBENZAMINE HYDROCHLORIDE 10MG CAPSULE / ORAL 2012-07-16 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENOXYBENZAMINE HYDROCHLORIDE ACTIVE INGREDIENT X1IEG24OHL PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 PHENOXYBENZAMINE ACTIVE MOIETY 0TTZ664R7Z PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0349-25 00054034925 100 CAPSULE in 1 BOTTLE (0054-0349-25) 100 capsule 2015-08-10 0000-00-00 No No Current