Home NDC 68084-846-01 Fluphenazine Hydrochloride
Product NDC 68084-846
Requested package NDC 68084-846-01
11-digit product format 680840846
Labeler code 68084
Product ID 68084-846_ea3f5929-0eeb-517b-e053-2995a90a1f33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluphenazine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA089742
Marketing category ANDA
Marketing start 2014-10-03
Marketing end 0000-00-00
Substance FLUPHENAZINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68084-846 68084-846-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68084-846 68084-846-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog .
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLUPHENAZINE HYDROCHLORIDE ACTIVE INGREDIENT ZOU145W1XL FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 FLUPHENAZINE ACTIVE MOIETY S79426A41Z FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3 WATER INACTIVE INGREDIENT 059QF0KO0R FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68084-846-01 68084084601 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-846-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-846-11) 100 blister pack 2020-12-01 0000-00-00 No No Current