Drug company (FDA labeler)

Padagis US LLC

NDC labeler code: 0574

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

29Prescription medicines

50Products (NDC)

37FDA applications

4Recalls

Prescription medicines

LenalidomideRevlimid · 6 products
TretinoinRetin-A, Retin-A Micro, Altreno · 5 products
Hydromorphone hydrochlorideDilaudid · 4 products
MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 4 products
Benazepril hydrochloride and hydrochlorothiazideLotensin Hct · 2 products
PodofiloxCondylox · 2 products
Testosterone cypionateDepo-Testosterone, Azmiro · 2 products
Trospium chloride2 products
Loteprednol etabonateLotemax, Lotemax Sm, Alrex · 2 products
Methazolamide2 products
Lidocaine and prilocaineOraqix · 1 product
Tobramycin and dexamethasoneTobradex St, Tobradex · 1 product
Bromocriptine mesylateCycloset · 1 product
Amiloride1 product
TofacitinibXeljanz, Xeljanz XR · 1 product
NystatinNystop, Klayesta, Nyamyc · 1 product
BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 product
Ciclopirox1 product
ClotrimazoleClotic (Clotrimazole) Otic Solution · 1 product
AcetylcysteineAcetadote · 1 product
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide1 product
SpironolactoneAldactone · 1 product
PhytonadioneVitamin K1 · 1 product
BrinzolamideAzopt · 1 product
Flavoxate hydrochloride1 product
MidazolamNayzilam · 1 product
EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 1 product
ProchlorperazineCompro · 1 product
ParoxetinePaxil, Paxil CR, Brisdelle · 1 product

FDA applications for these products

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ANDA: Abbreviated New Drug Application: how a generic version is approved.

Approved	Application	Medicine	Sponsor
February 26, 2026	ANDA220454	Phytonadione PHYTONADIONE	Novax
September 30, 2025	ANDA216001	Tofacitinib TOFACITINIB CITRATE	Sinotherapeutics Inc
January 29, 2025	ANDA215204	Loteprednol etabonate LOTEPREDNOL ETABONATE	Padagis Us
July 10, 2024	ANDA215203	Loteprednol etabonate LOTEPREDNOL ETABONATE	Padagis Us
February 22, 2024	ANDA217265	Lenalidomide LENALIDOMIDE	Qilu
November 22, 2023	ANDA211871	Podofilox PODOFILOX	Padagis Us
July 28, 2023	ANDA211914	Brinzolamide BRINZOLAMIDE	Padagis Us
February 11, 2022	ANDA212715	Tobramycin and dexamethasone TOBRAMYCIN AND DEXAMETHASONE	Padagis Us
July 27, 2021	ANDA212482	Lidocaine and prilocaine LIDOCAINE AND PRILOCAINE	Padagis Us
August 4, 2017	NDA209478	Spironolactone CAROSPIR	Cmp Dev LLC
April 6, 2015	ANDA204278	Hydromorphone hydrochloride HYDROMORPHONE HYDROCHLORIDE	Padagis Us
July 15, 2014	ANDA205292	Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	Padagis Us
June 28, 2013	NDA204516	Paroxetine BRISDELLE	Legacy
May 24, 2013	ANDA201291	Trospium chloride TROSPIUM CHLORIDE	Padagis Us
May 1, 2012	ANDA091244	Testosterone cypionate TESTOSTERONE CYPIONATE	Hikma Farmaceutica
November 17, 2010	ANDA091573	Trospium chloride TROSPIUM CHLORIDE	Padagis Us
January 7, 2009	ANDA078266	Ciclopirox CICLOPIROX	Padagis Us
October 1, 2008	ANDA077646	Bromocriptine mesylate BROMOCRIPTINE MESYLATE	Padagis Us
July 27, 2007	NDA022014	Estradiol EVAMIST	Padagis Us
April 6, 2006	NDA021514	Methylphenidate DAYTRANA	Noven Pharms Inc
October 28, 2005	ANDA076763	Clotrimazole CLOTRIMAZOLE	Padagis Us
May 2, 2005	ANDA076379	Midazolam MIDAZOLAM HYDROCHLORIDE	Padagis Us
January 31, 2005	ANDA040530	Testosterone cypionate TESTOSTERONE CYPIONATE	Padagis Us
December 16, 2004	ANDA076831	Flavoxate hydrochloride FLAVOXATE HYDROCHLORIDE	Padagis Us
January 23, 2004	NDA021539	Acetylcysteine ACETADOTE	Apotex

Show the other 12 applications

Approved	Application	Medicine	Sponsor
June 11, 2002	ANDA075589	Tretinoin TRETINOIN	Padagis Us
January 29, 2002	ANDA075600	Podofilox PODOFILOX	Padagis Us
October 2, 2001	NDA021324	Budesonide ENTOCORT EC	Padagis Us
June 28, 2000	ANDA040246	Prochlorperazine COMPRO	Padagis Us
February 22, 2000	ANDA075529	Tretinoin TRETINOIN	Padagis Us
December 24, 1998	ANDA075213	Tretinoin TRETINOIN	Padagis Us
December 24, 1998	ANDA075264	Tretinoin TRETINOIN	Padagis Us
December 24, 1998	ANDA075265	Tretinoin TRETINOIN	Padagis Us
August 16, 1996	ANDA064118	Nystatin NYSTOP	Padagis Us
January 27, 1994	ANDA040062	Methazolamide METHAZOLAMIDE	Pharmobedient
May 19, 1992	NDA020033	Benazepril hydrochloride and hydrochlorothiazide LOTENSIN HCT	Validus Pharms
October 5, 1981	NDA018200	Amiloride MIDAMOR	Padagis Us

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2023

November 1, 2023 · Class II · Ongoing · D-0139-2024 · Trospium chloride

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand,
February 21, 2023 · Class III · Ongoing · D-0464-2023 · Estradiol

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan,

2021

March 15, 2021 · Class II · Terminated · D-0549-2021 · Podofilox

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05.

2018

February 26, 2018 · Class II · Terminated · D-0608-2018 · Estradiol

Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Next steps

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Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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