Attachment 1 Comprehensive Drug Products list.xlsx

XLSX spreadsheet 26 KB Posted

Attached to
Pharmaceutical Products for CDER Research Studies - IDIQ
Solicitation number
75F40126Q132721
Issued by

About this file

This is a Comprehensive Drug Products List that serves as an attachment to a pharmaceutical solicitation for the Food and Drug Administration's Center for Drug Evaluation and Research (CDER). The document outlines a drug purchase forecast containing 96 pharmaceutical products with varying formulations, strengths, package sizes, NDC numbers, and manufacturers/distributors. Each product is listed with a quantity of one unit designated for evaluation purposes only, with notation that actual ordering quantities may vary.

The products span multiple therapeutic categories including respiratory inhalers (Advair Diskus, Spiriva Respimat, Trelegy Ellipta), injectable medications (Abraxane, AmBisome, Exondys 51), oral tablets and capsules (Concerta, Tamiflu, Ziagen), ophthalmic suspensions (Tobradex, Tobrex), intrauterine devices (Mirena, Paragard T 380A, Skyla), and specialty pharmaceuticals such as Narcan, Vivitrol, and Victoza. The spreadsheet includes columns for five ordering periods with unit pricing fields, though all pricing cells display $0.00, indicating this is a template or evaluation document where actual pricing has not yet been populated. The list also contains a total evaluated price row across all five ordering periods. This comprehensive product list establishes the scope of pharmaceutical items potentially subject to ordering under the CDER Research Studies Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicle.

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Drug purchase forecast

Product NameStrengthSizeNDC Number (if avail)Manufacturer/ DistributorQty for evaluation purposes only (may vary when ordering)Ordering Period 1 Price/ UnitOrdering Period 2 Price/ UnitOrdering Period 3 Price/ UnitOrdering Period 4 Price/ UnitOrdering Period 5 Price/ UnitNotes
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg100 tablets/bottle00527-0766-371
Budesonide; Formoterol Fumarate Glycopyrrolate Metered Inhalation Aerosol0.16 mg/inh; 0.005mg/inh; 0.0072 mg/inh1 inhaler/unit1
ABRAXANE (paclitaxel albumin-bound injectable suspension)100mg/vial1 in 1 CARTON68817-134-501
ADASUVE (loxapine inhalation aerosol powder)10mg5 in 1 CARTON10885-003-051
ADRENACLICK (epinephrine injection)EQ 0.15MG/DELIVERY1
ADVAIR DISKUS (fluticasone propionate and salmeterol powder)0.5MG/INH; EQ 0.05MG BASE/INH60 in 1 INHALER0173-0695-001
AMBISOME (amphotericin B injection, powder, lyophilized, for solution)50mg/vial1 vial0469-3051-301
AZILECT (Rasagiline Mesylate) Tablet1mgbottle of 301
BYDUREON BCISE (exenatide injection, suspension, extended release)2 MG1 in 1 carton and 4 in 1 carton0310-6540-85 and 0310-6540-041
CARAFATE (sucralfate suspension)1GM/10ML1
CONCERTA (methylphenidate hydrochloride tablet, extended release)54mgbottle of 10050458-587-011
CORGARD (nadolol tablet)80mgbottle of 1001
CUPRIMINE (penicillamine capsule)250mgbottle of 1001
DEFINITY (perflutren injection, suspension)6.52mg/mLBox containing 16 vials (2mL)11994-011-161
DEPEN (penicillamine tablet)250mgbottle of 1000037-4401-011
DEXILANT (dexlansoprazole capsule, delayed release)30mg1
DIPRIVAN (propofol injection, emulsion)10mg/mL1
DOXIL (doxorubicin liposomal injection)20mg/10mL1
Effexor XR (venlafaxine hydrochloride capsule, extended release)150mg1
EPIPEN JR (epinephrine injection)0.15MG/DELIVERY1
EXONDYS 51(eteplirsen injection)100mg/2mL60923-363-021
EXPAREL (bupivacaine injection, suspension, liposomal)266MG/20ML (13.3MG/ML)Box containing 10 vials, each vial containing 20 mL1
FIRMAGON (degarelix)120mg/vial1
FORTEO (teriparatide injection, solution)0.6MG/2.4ML (0.25MG/ML)1
HYSINGLA ER (hydrocodone bitartrate tablet, extended release)120mg1
INJECTAFER (ferric carboxymaltose injection injection, solution)750MG IRON/15ML (50MG IRON/ML)1
LOTEMAX (loteprednol etabonate suspension/drops)0.50%1
LUMASON (sulfur hexaflouride)60.7MG/25MG0270-7099-161
MIACALCIN (calcitonin salmon injection, solution)200IU/ml1 in 1 carton67457-675-021
MIRENA (levonorgestrel intrauterine device)52mg1
NARCAN (naloxone hydrochloride Spray)4MG/SPRAY1
NEXIUM (esomeprazole magnesium granule, delayed release)EQ 40MG BASE/PACKET1
Ozurdex (dexamethasone implant)0.7mg1
PARAGARD T 380A (copper intrauterine device)309MG/COPPER1
PENTASA (mesalamine capsule)500mg1
PREMARIN (conjugated estrogens vaginal cream)0.625MG/GM1
PREVACID (lansoprazole tablet, orally disintegrating, delayed release)30mg1
PROAIR RESPICLICK (albuterol sulfate powder, metered)EQ 0.090MG BASE/INH1
PROTONIX DELAYED-RELEASE(pantoprazole sodium granule, delayed release)40mg1
QVAR REDIHALER (beclomethasone dipropionate hfa aerosol, metered)0.04MG/INH1
RASUVO (methotrexate injection, solution)7.5MG/0.15ML (7.5MG/0.15ML)1
RESTASIS (cyclosporine emulsion)0.05%1
RISPERDAL CONSTA (risperidone injection)50MG/VIAL1
SANDOSTATIN LAR DEPOT (octreotide acetate)30mg1
SKYLA (levonorgestrel intrauterine device)13.5mg1
SPINRAZA (nusinersen injection, solution)12mg/5mL64406-058-011
SPIRIVA RESPIMAT (tiotropium bromide inhalation spray spray, metered)EQ 0.0025MG BASE/INH0597-0100-611
STRIVERDI RESPIMAT (olodaterol respimat inhalation spray spray, metered)EQ 0.0025MG BASE/INH0597-0192-611
Tacrolimus1
TAMIFLU (oseltamivir phosphate capsule)EQ 75MG BASE1
TENORMIN (atenolol tablet)100mgbottle of 1001
TESTOPEL (testosterone pellet)75mg1
TIMOPTIC-XE (timolol maleate solution)0.25%1
TOBI PODHALER (tobramycin capsule)28MG1
TOBREX (tobramycin ophthalmic suspension)0.30%1
TOBRADEX (tobramycin/dexamethasone ophthalmic suspension)0.3%/0.1%1
TOBRADEX ST (tobramycin/dexamethasone ophthalmic suspension)0.3%/0.05%1
TRELEGY ELLIPTA (fluticasone furoate, umeclidinium bromide and vilanterol trifenatate powder)0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH0173-0887-10 or 0173-0887-141
TRELSTAR (triptorelin pamoate)22.5mg1
TYMLOS (abaloparatide injection, solution)3.12MG/1.56ML (2MG/ML)1
TYVASO (treprostinil inhalant)0.6MG/ML1
UCERIS (budesonide aerosol, rectal foam)2MG/ACTUATION1
VELPHORO (sucroferric oxyhydroxide tablet, chewable)500mg49230-645-511
VELTASSA (patiromer powder, for suspensionr)EQ 8.4GM BASE/PACKET1
VICTOZA (liraglutide injection)18MG/3ML (6MG/ML)1
VIDAZA (azacitidine injection, powder, lyophilized, for solution)100mg/vial1
VIVITROL (naltrexone injection)380mg1
VYXEOS (daunorubicin and cytarabine liposome injection, powder, lyophilized, for suspension)44mg/100mg1
XERESE (acyclovir and hydrocortisone cream)5%; 1%1 in 1 CARTON0187-5104-011
XHANCE (fluticasone propionate spray, metered)0.093MG1
XOPENEX HFA (levalbuterol tartrate aerosol, metered)EQ 0.045 MG BASE/INH1
XTAMPZA ER (oxycodone capsule, extended release)36mg1
XULTOPHY 100/3.6 (insulin degludec and liraglutide injection, solution)100 UNITS/ML;3.6MG/ML1
ZIAGEN (abacavir sulfate tablet, film coated)EQ 300MG BASE1
Total Evaluated Price$0.00$0.00$0.00$0.00$0.00

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