Labeler · US market

Appco Pharma LLC

Appco Pharma LLC is a US drug labeler with US FDA registrations covering 4 drug concepts (4 currently active) across 20 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes55801

Active drugs4

Registrations9 active / 9

Packages20

Sole supplier of1 drugs

Portfolio4 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Sildenafil tablet	rx	3	9	SUPPLYING
Doxepin Hydrochloride capsule	rx	4	8	SUPPLYING
Doxepn Hydrochloride capsule	rx	1	2	SUPPLYING
Clomiphene Citrtae tablet	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Doxepn Hydrochloriderx

At a glance

TypeLabeler
Labeler codes55801
Filing names1
Drugs (active)4
Drugs (all time)4
US registrations9
Packages20

Recent events

Shortages, recalls, and registration changes across all filing names.

Mar 27, 2026
RECALLRecall (Class II): Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,…
Mar 27, 2026
RECALLRecall (Class II): Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ…
Mar 27, 2026
RECALLRecall (Class II): Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,…
Jan 16, 2025
RECALLRecall (Class III): Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Jan 7, 2020
RECALLRecall (Class II): Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distrib…
Jan 7, 2020
RECALLRecall (Class II): Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.