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FDCA Stuff

Terms in this set (16)

1. Sublingual dosage forms of nitroglycerin
2. Sublingual and chewable forms of isosorbide dinitrate in strengths of 10mg or less
3. Sodium fluoride products containing not more than 110mg of sodium fluoride per package (like the tootpaste)
4. Anhydrous cholestyramine in powder form
5. Methylprednisolone tablets containing not more than 84mg of the drug per package and containing no other substances (aka Medrol dosepak 4mg*21tab)
6. Mebendazole tablets containing not more than 600mg of the drug per package
7. Betamethasone tablets containing not more than 12.6mg of the drug per package
8. Potassium supplements in unit dose forms including effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit dose packets containing not more than 50mEq per unit dose
9. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 g of the equivalent of erythromycin
10. Colestipol in powder form up to 5g in a packet
11. Erythromycin ethylsuccinate tablets in packages containing no more than 16g of the drug
12. Preparations in aerosol containers intended for inhalation therapy
13. Pancrelipase preparations in tablet, capsule, or powder form containing no other substances
14. Prednisone tablets containing nor more than 105mg per package and containing no other substances
15. Cyclically administered oral contraceptives, conjugated estrogens (not more than 32mg of drug), and norethindrone acetate tablets(no more than 50mg of drug) in manufacturer's memory-aid (mnemonic) dispenser packages
16. Medroxyprogesterone acetate tablets
17. Sacrosidase (Sucrase) preparations in a solution of glycerol and water
18. Hormone Replacement Therapy Products that rely solely on the activity of one or more progesterone or estrogen substances
19. Oral dosage form products containing aspirin and acetaminophen must comply with the act's packaging requirements except:
I. effervescent tablets containing ASA or APAP other than those intended for pediatric use. The dry tablet must contain less than 15 percent of ASA or APAP, the tablet must have an oral LD50 in rates of greater than 5g/kg body weight
II. Unflavored ASA or APAP containing preparations in powder for, not intended for pediatric use, that are packaged in unit doses providing not more than 15.4 grains of ASA per unit dose and that contain no other substances subject to the provisions of the act
III. Colesevelam hydrochloride in powder form in packages containing not more than 3.75 grams of the drug.
0. Sevelamer carbonate in powder form in packages containing not more than 2.4 grams of the drug.