Labeler · US market

TOLMAR Inc.

TOLMAR Inc. is a US drug labeler with US FDA registrations covering 5 drug concepts (5 currently active) across 15 packages.

ACTIVE — US

openFDA · updated weekly

Labeler codes62935 · 63646 · 69087

Active drugs5

Registrations14 active / 14

Packages15

Sole supplier of0 drugs

Portfolio5 drugs · US

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

Drug	Type	NDCs	Packages	Status
Leuprolide Acetate injection, suspension, extended release	rx	5	5	SUPPLYING
Leuprolide Acetate kit	rx	4	4	SUPPLYING
Testosterone Undecanoate capsule, liquid filled	rx	3	4	SUPPLYING
Leuprolide Acetate kit	rx	1	1	SUPPLYING
Ketoconazole shampoo, suspension	rx	1	1	SUPPLYING

At a glance

TypeLabeler
Labeler codes62935, 63646, 69087
Filing names1
Drugs (active)5
Drugs (all time)5
US registrations14
Packages15

Recent events

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

Sep 12, 2023
RECALLRecall (Class III): Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted bef…
Jul 11, 2022
RECALLRecall (Class II): Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g t…
Nov 8, 2021
RECALLRecall (Class II): Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-726…
Sep 23, 2013
RECALLRecall (Class III): Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-709…

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.