NDC Product Details

Upon clicking an NDC A unique 11-digit, 3-segment code numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment (4 or 5 digits) is assigned by the Food and Drug Administration (FDA). The second segment (3 or 4 digits) identifies a specific strength, dosage form, and formulation for a particular firm. The third segment (1 or 2 digits) identifies package forms and sizes. on the Ceiling Price Manufacturers who participate in the Medicaid Drug Rebate Program (MDRP) enter into an agreement with the Secretary of Health and Human Services under which the manufacturer must agree to charge a price no greater than the statutory pricing formula (340B ceiling price) when selling covered outpatient drugs to 340B covered entities. In order to calculate the 340B ceiling price, the Unit Rebate Amount (URA) is subtracted from the Average Manufacturer Price (AMP) for the smallest unit of measure [340B Ceiling Price = (AMP – URA)]. Under section 340B(a) of the Public Health Service Act (PHSA), the 340B ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure of each covered outpatient drug (as identified by the product's 11-digit National Drug Code (NDC). To ensure that the final price is operational in the marketplace, HRSA then multiplies this amount by drug's package size (PS), defined as the number of billing units in the labeled quantity from which the pharmacist dispenses, and the case pack size (CSP), defined as the number of salable units in the shipping container [340B Ceiling Price = (AMP-URA) x PS x CSP]. page, the Product Details page is displayed.

• The left side of the page shows the Manufacturer Contact Information and Product Information.

  • The Manufacturer Contact Information section shows the manufacturer name, contact name and email address, and the manufacturer's city, state, and ZIP code.

  • The Product Information section shows the National Drug Code (NDC), market date, brand name, termination date (if applicable), drug category, FDB unit type, drug type, and CMS Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit. unit type.

• The right side of the page contains the Ceiling Price Chart showing the ceiling price by effective year and quarter. The associated information is listed in grid format below the chart, including NDC, effective date ceiling price (AMP – URA The CMS Medicaid Drug Rebate (MDR) system performs the URA calculation using the drug manufacturer's pricing. The specific methodology used is determined by law and depends upon the drug's classification. Drug manufacturers remain responsible for correctly calculating the URA for their covered outpatient drugs.), package adjusted price (ceiling price multiplied by the drug's package size and case package size).

  • The asterisks (****) in the Flag column denote that the product is a New Drug Price Estimate

• Hover over a bar in the ceiling price chart to view the associated price.

• The following Flags denote that there has been a price correction: (c) – This is the corrected price for this quarter. (x) – This price has been corrected at a later point and is no longer valid.

• Click the Back button to return to the Ceiling Price page.