|
1) This is a required free form field
Manufacturer's Name |
1) This is a requred field if Alternate ID is left blank
2) 5 digit number which identifies the labeler.
NDC1 |
1) This is a requred field if Alternate ID is left blank
2) 4 digit number which identifies the product.
NDC2 |
1) This is a requred field if Alternate ID is left blank
2) 2 digit number which identifies the package size.
NDC3 |
1) This is a required field if NDC1, NDC2, or NDC3 is left blank.
2) Numeric or alphanumeric alternate drug identifier (ex. An NHRIC number) can be entered.
3) Value must be 13 characters or less.
AlternateID |
1) This is a required field
2) Value must be any positive or negative numbers including zero
3) Value must include three decimal places.
4) ASP should not be greater than WAC but ASP could be greater than WAC
5) "$" is not an allowed value.
Note: The CMS validation macro will flag an NDC if the ASP is greater than WAC .
Manufacturer's
Average Sales Price |
1) This is a required field
2) Must show three decimal places
3) Must be any valid positive or negative number including zero
Number of ASP Units |
1) This is a required field
2) WAC must be a valid or positive number including zero
3) Value must include three decimal places.
4) "$" is not an allowed value.
Wholesale
Acquisition Cost |
1) This is a required free form field
2) Must be alphanumeric limited to 100 characters
Name of Drug or Biological |
1) This is a required field free form field
2) Must be alphanumeric limited to 500 characters
Strength of the Product |
1) This is a required free form field
2) Limited to no more than 12 alphanumeric characters
Volume
Per Item |
1) This is a required field
2) Must be limited to a 10 digit numeric value
Number of Items Per NDC |
1) This is not a required field
2) Value must be in date format (MM/DD/YYYY)
Expiration Date of Final Lot Sold |
1) This is a required field
2) Value must be in date format (MM/DD/YYYY)
Date of First Sale |
1) This is not a required field
2) Data must be numeric and show three decimal places.
Number of CAP Units Excluded |
1) This is a required field
2) Data may include a mixture of alpha numeric and numeric values
3) Value is limited to 6 or 7 characters
4) Character should not include dashes.
5) Field should not include blanks.
FDA Application Number |
1) This is not a required field
2) Data may include a mixture of alpha numeric and numeric values
3) Value is limited to 4 numeric characters
FDA Application Supplement Number |
1) This is not a required field
2) Data may include a mixture of alpha numeric and numeric values
3) Value is limited to 6 or 7 characters
4) Character should not include dashes.
Additional FDA Application Number #1 |
1) This is not a required field
2) Data may include a mixture of alpha numeric and numeric values
3) Value is limited to 4 characters
Additional FDA Application Supplement Number #1 |
1) This is not a required field
2) Data may include a mixture of alpha numeric and numeric values
3) Value is limited to 6 or 7 characters
4) Character should not include dashes.
Additional FDA Application Number #2 |
1) This is not a required field
2) Data may include a mixture of alpha numeric and numeric values
3) Value is limited to 4 characters
Additional FDA Application Supplement Number #2 |
1) This is a required field
2) Value must be in date format (MM/DD/YYYY)
3) if there is no approval date, baseline date should be set to 01/01/1965
FDA Final Pre-Marketing Approval Date |
1) This is a required field
2) Must only be values in FDA approval type list (ANDA, NDA, 510K, BLA, PMA, Human Tissue, Vaccine, Other)
FDA Approval Type |
1) This is a required field if the FDA Approval Type is categorized as OTHER.
This field should not be populated otherwise.
Description of FDA Approval Type |
1) This is not a required field. Freeform field.
Descriptive Data Corrected |
|
|
