Labeler · US market

KVK-TECH, Inc.

KVK-TECH, Inc. is a US drug labeler with US FDA registrations covering 35 drug concepts (35 currently active) across 171 packages. It is currently the only active US supplier of 5 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes10702

Active drugs35

Registrations71 active / 71

Packages171

Sole supplier of5 drugs

Portfolio35 drugs · US

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

Drug	Type	NDCs	Packages	Status
Hydrocodone Bitartrate And Acetaminophen tablet	rx	6	24	SUPPLYING
Phentermine Hydrochloride tablet	rx	3	12	SUPPLYING
Phentermine Hydrochloride capsule	rx	4	12	SUPPLYING
Oxycodone And Acetaminophen tablet	rx	4	12	SUPPLYING
Oxycodone Hydrochloride tablet	rx	5	10	SUPPLYING
Hydroxyzine Hydrochloride tablet, film coated	rx	3	9	SUPPLYING
Phendimetrazine Tartrate tablet	rx	3	9	SUPPLYING
Cyclobenzaprine Hydrochloride tablet, film coated	rx	2	8	SUPPLYING
Promethazine Hydrochloride tablet	rx	3	7	SUPPLYING
Dextroamphetamine Sulfate tablet	rx	2	6	SUPPLYING
Indomethacin capsule, extended release	rx	1	6	SUPPLYING
Benzphetamine Hydrochloride tablet	rx	1	4	SUPPLYING
Methylphenidate Hydrochloride Extended Release tablet	rx	2	4	SUPPLYING
Hydrocodone Bitartrate And Homatropine Methylbromide tablet	rx	1	4	SUPPLYING
Oxymorphone Hydrochloride tablet	rx	2	4	SUPPLYING
Chlorpheniramine Maleate tablet, film coated, extended release	otc	1	4	SUPPLYING
Dexmethylphenidate Hydrochloride tablet	rx	3	3	SUPPLYING
Methylphenidate Hydrochloride tablet	rx	3	3	SUPPLYING
Diethylpropion Hydrochloride tablet	rx	1	3	SUPPLYING
Oxybutynin Chloride tablet	rx	1	3	SUPPLYING
Sodium Polystyrene Sulfonate powder	rx	1	2	SUPPLYING
Leflunomide tablet	rx	2	2	SUPPLYING
Cyclosporine emulsion	rx	1	2	SUPPLYING
Butalbital, Acetaminophen, And Caffeine tablet	rx	1	2	SUPPLYING
Desmopressin Acetate tablet	rx	2	2	SUPPLYING
Methylphenidate Hydrochloride solution	rx	2	2	SUPPLYING
Oxycodone Hydrochloride solution	rx	2	2	SUPPLYING
Betaxolol Hydrochloride tablet, coated	rx	2	2	SUPPLYING
Oxycodone Hydrochloride capsule	rx	1	2	SUPPLYING
Isoproterenol Hydrochloride injection, solution	rx	1	1	SUPPLYING
Ursosiol capsule	rx	1	1	SUPPLYING
Carmustine kit	rx	1	1	SUPPLYING
Oxycodone And Acetaminophen solution	rx	1	1	SUPPLYING
Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution liquid	rx	1	1	SUPPLYING
Atovaquone suspension	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.

At a glance

TypeLabeler
Labeler codes10702
Filing names1
Drugs (active)35
Drugs (all time)35
US registrations71
Packages171

Recent events

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

May 9, 2025
RECALLRecall (Class II): Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, M…
May 9, 2025
RECALLRecall (Class II): Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 189…
Sep 20, 2023
RECALLRecall (Class I): Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 1…
Jul 2, 2021
RECALLRecall (Class I): Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC …
Apr 27, 2021
RECALLRecall (Class III): Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-…
Dec 18, 2020
RECALLRecall (Class III): Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., …
Nov 1, 2019
RECALLRecall (Class II): Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. …
Oct 4, 2019
RECALLRecall (Class III): Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK T…

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.