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Drug company (FDA labeler)

Laurus Labs Limited

NDC labeler code: 42385

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

21Prescription medicines
51Products (NDC)
26FDA applications
0Recalls

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
August 20, 2026ANDA218869 Ticagrelor
TICAGRELOR		Pharmobedient
July 10, 2026ANDA219788 Rilpivirine hydrochloride
RILPIVIRINE HYDROCHLORIDE		Laurus
April 21, 2026ANDA218897 Valsartan
VALSARTAN		Pharmobedient
March 4, 2026ANDA220232 Emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE		Laurus
November 5, 2025ANDA211120 Macitentan
MACITENTAN		Laurus
July 23, 2025ANDA218005 Flucytosine
FLUCYTOSINE		Pharmobedient
May 28, 2024ANDA213676 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Laurus
May 1, 2024ANDA218565 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE		Laurus
April 8, 2024ANDA217965 Gabapentin
GABAPENTIN		Pharmobedient
January 22, 2024ANDA214513 Atorvastatin
ATORVASTATIN CALCIUM		Laurus
October 5, 2023ANDA217631 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Laurus
May 12, 2023ANDA217546 Gabapentin
GABAPENTIN		Pharmobedient
July 25, 2022ANDA216332 Abacavir and lamivudine
ABACAVIR SULFATE AND LAMIVUDINE		Laurus
July 19, 2022ANDA212722 Pirfenidone
PIRFENIDONE		Laurus
July 19, 2022ANDA212724 Pirfenidone
PIRFENIDONE		Laurus
March 21, 2022ANDA213857 Lopinavir and ritonavir
LOPINAVIR AND RITONAVIR		Laurus
December 22, 2021ANDA213541 Efavirenz, emtricitabine and tenofovir disoproxil fumarate
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE		Laurus
April 30, 2021ANDA212579 Atazanavir
ATAZANAVIR SULFATE		Laurus
May 14, 2020ANDA212786 Efavirenz, lamivudine and tenofovir disoproxil fumarate
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE		Laurus
May 14, 2020ANDA213038 Efavirenz, lamivudine and tenofovir disoproxil fumarate
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE		Laurus
March 18, 2020ANDA211122 Fenofibrate
FENOFIBRATE		Rising
February 12, 2020ANDA213200 Ursodiol
URSODIOL		Rising
July 26, 2019ANDA212114 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE		Laurus
January 15, 2019ANDA210959 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE		Laurus
August 27, 2018ANDA209882 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Laurus
Show the other 1 applications
ApprovedApplicationMedicineSponsor
August 17, 2018ANDA210606 Fenofibrate
FENOFIBRATE		Rising

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

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. 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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