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NDC/NDA/DEA Info

Nat'l Dug Codes, DEA # Info, and New Drug App.

QuestionAnswer
First set of numbers in a NDC 5 numbers representing the manufacturer
Second set of numbers in a NDC 4 numbers representing the product and its strength/dosage
Last set of numbers in a NDC 2 numbers representing the # of pills in the bottle
If you are typing a NDC into the computer and it doesn't have enough #s, you add a zero at the ____ of the set. Beginning
NDC #s can be found... In the red book in each pharmacy
Phase 1 Used to get maximum tolerated dose (how much of the medication can be tolerated before it causes death); takes 1-2 years
Phase 2 Effectiveness of the drug (does it do what we say it does?); takes 2-3 years
Phase 3 Double-blind study (advertise to public for human testing); 3-4 years
Phase 4 After the NDA is submitted to FDA; all drugs that are approved and on the market are here; patients can report side effects of this medication
The FDA has _____ to approve a NDA. 6 months to 1 year
A generic cannot be made for ___ years after a drug has been introduced. 4 years
Side effects are reported on... Med Watch form
A doctor's DEA # has... 2 letters and 7 numbers
2nd letter in DEA # is... First letter of last name
Created by: ABPharmTech2
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