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Drug company (FDA labeler)

Prasco Laboratories

NDC labeler code: 66993

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

105Products (NDC)

Prescription medicines

Show the other 2 medicines

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.
ApprovedApplicationMedicineSponsor
January 18, 2023ANDA216751 Mirtazapine
MIRTAZAPINE
Prasco
July 15, 2021ANDA212313 Estradiol
ESTRADIOL
Prasco
May 16, 2018NDA209229 Lofexidine hydrochloride
LUCEMYRA
Biocorrx Pharms
July 31, 2015NDA207958 Levetiracetam
SPRITAM
Aprecia Pharms
October 29, 2014NDA205649 Dapagliflozin and metformin hydrochloride
XIGDUO XR
Astrazeneca Ab
August 20, 2014NDA205625 Fluticasone furoate
ARNUITY ELLIPTA
Glaxosmithkline
April 30, 2014NDA205382 Umeclidinium
INCRUSE ELLIPTA
Glaxo Grp England
January 8, 2014NDA202293 Dapagliflozin
FARXIGA
Astrazeneca Ab
December 18, 2013NDA203975 Umeclidinium bromide and vilanterol trifenatate
ANORO ELLIPTA
Glaxosmithkline
May 10, 2013NDA204275 Fluticasone furoate and vilanterol trifenatate
BREO ELLIPTA
Glaxo Grp Ltd
July 17, 2012NDA022580 Phentermine and topiramate
QSYMIA
Vivus LLC
February 10, 2012NDA202514 Tafluprost
ZIOPTAN
Thea Pharma
April 29, 2011NDA022309 Testosterone
ANDROGEL
Besins Hlthcare
January 29, 2008ANDA040776 Dextroamphetamine
DEXTROAMPHETAMINE SULFATE
Prasco
March 5, 2007NDA021985 Aliskiren hemifumarate
TEKTURNA
Lxo Ireland
November 13, 2006ANDA077612 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Prasco
July 28, 2006NDA021925 Pioglitazone and glimepiride
DUETACT
Takeda Pharms USA
June 28, 2006NDA021986 Dasatinib
SPRYCEL
Bristol Myers Squibb
June 8, 2006NDA021254 Fluticasone propionate and salmeterol
ADVAIR HFA
Glaxo Grp Ltd
April 13, 2006NDA021903 Ibuprofen lysine
NEOPROFEN
Recordati Rare
January 9, 2006NDA021852 Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene monohydrate)
TACLONEX
Leo Pharma As
October 26, 2004NDA021468 Lanthanum carbonate
FOSRENOL
Takeda Pharms USA
May 14, 2004NDA021433 Fluticasone propionate
FLOVENT HFA
Glaxo Grp Ltd
January 30, 2004NDA021540 Amlodipine and atorvastatin
CADUET
Pharmacia
November 26, 2002NDA021318 Teriparatide
FORTEO
Lilly
Show the other 21 applications
ApprovedApplicationMedicineSponsor
October 11, 2001NDA021303 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
ADDERALL XR 10, ADDERALL XR 15, ADDERALL XR 20
Takeda Pharms USA
October 3, 2001NDA021187 Etonogestrel and ethinyl estradiol
NUVARING
Organon USA Organon
April 19, 2001NDA020983 Albuterol sulfate
VENTOLIN HFA
Glaxosmithkline
September 29, 2000NDA020833 Fluticasone propionate
FLOVENT DISKUS 100, FLOVENT DISKUS 250, FLOVENT DISKUS 50
Glaxo Grp Ltd
August 24, 2000NDA021077 Fluticasone propionate and salmeterol
ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, ADVAIR DISKUS 500/50
Glaxo Grp Ltd
July 14, 2000NDA021078 Atovaquone and proguanil hydrochloride
MALARONE, MALARONE PEDIATRIC
Glaxosmithkline
February 28, 2000NDA021015 Testosterone
ANDROGEL
Besins Hlthcare
August 26, 1997NDA020626 Sumatriptan
IMITREX
Glaxosmithkline
July 22, 1996NDA020554 Calcipotriene
DOVONEX
Leo Pharma As
September 20, 1995NDA020531 Metronidazole
METROCREAM
Galderma Labs LP
February 2, 1995NDA020356 Nisoldipine
SULAR
Azurity
December 29, 1993NDA020273 Calcipotriene
DOVONEX
Leo Pharma As
October 29, 1992NDA020246 Medroxyprogesterone acetate
DEPO-PROVERA
Pfizer
October 31, 1985NDA018705 Nitroglycerin
NITROLINGUAL, NITROLINGUAL PUMPSPRAY
Pohl Boskamp
July 27, 1983NDA018741 Betamethasone dipropionate
DIPROLENE
Organon
February 26, 1979ANDA084427 Phenytoin
DILANTIN
Pharmacia
June 23, 1976NDA017442 Prazosin hydrochloride
MINIPRESS
Pfizer
October 20, 1971ANDA080399 Dexamethasone
DEXAMETHASONE
Prasco
August 10, 1964NDA013174 Triamterene
DYRENIUM
Advanz Pharma
January 27, 1961NDA012616 Spironolactone and hydrochlorothiazide
ALDACTAZIDE
Pfizer
May 8, 1942NDA004782 Estrogens, conjugated
PREMARIN
Wyeth Pharms

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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