Guides for billers and coders
NDC & J-Code Guides
One question per page, answered in the first sentence. Written for billers and coders who need the rule, the reason and a worked example.
NDC
- What is a National Drug Code (NDC)?A National Drug Code is the FDA's universal product identifier for a human drug — a three-segment number that names the company responsible for the label, the specific formulation, and the package size it was sold in.
- How do I decode the three segments of an NDC number?Read an NDC left to right as labeler, product, package: the first segment (4-5 digits) is the company, the second (3-4 digits) is the formulation and strength, and the third (1-2 digits) is the package size.
- How do I convert a 10-digit NDC to the 11-digit billing format?Insert a single leading zero into whichever segment is one digit short: 4-4-2 pads the first segment, 5-3-2 pads the second, 5-4-1 pads the third — always producing a 5-4-2 code, and never simply adding a zero to the front of the whole number.
- What is the difference between a Product NDC and a Package NDC?A product NDC has two segments and identifies a formulation regardless of packaging; a package NDC has three segments and identifies an exact box — and only the package NDC is billable.
- What do NDA, ANDA and BLA marketing categories mean?The marketing category states the legal basis on which a drug is sold: NDA for a brand-name drug approved on its own evidence, ANDA for a generic proved bioequivalent to that brand, and BLA for a licensed biological product.
- Where does Med-Code get its NDC and drug data?NDC records come from the FDA NDC Directory and label information from FDA Structured Product Labeling, both through openFDA, the FDA's public data service. Trial records come from ClinicalTrials.gov. The drug-to-HCPCS directory is curated by Med-Code and should be checked against the current CMS HCPCS file.
- How do I find and verify an NDC number?The NDC is printed on the drug's package and label, usually near the product name and prefixed with "NDC". To confirm it, look it up in the FDA NDC Directory and check that the listing is current, that the package code matches the package in your hand, and that you are using the package NDC rather than the product NDC.
- How do you report an NDC, its unit of measure and quantity on a claim?On a drug claim line, the NDC is reported as the qualifier N4 followed by the 11-digit NDC with no hyphens, then a unit-of-measure qualifier (F2, GR, ME, ML or UN) and the quantity of that NDC product used. The HCPCS code and its units are reported on the same line.
HCPCS and J-codes
- What is a HCPCS J-code?A J-code is a HCPCS Level II code beginning with the letter J. CMS uses the J range mainly for drugs that are administered other than by mouth, such as injections and infusions given in a clinic, and for chemotherapy drugs.
- What is the difference between an NDC and a J-code?An NDC identifies a specific drug product and package as listed with the FDA. A J-code is a HCPCS billing code that describes a drug and a dosage amount regardless of who made it or how it is packaged. One J-code usually covers many NDCs, and many NDCs have no J-code.
- What is the difference between an NDC and a HCPCS code?An NDC identifies a specific drug product and package listed with the FDA. A HCPCS code identifies a service, supply or drug for billing: Level I (CPT) covers procedures and services, and Level II covers drugs, supplies and equipment. Drugs given in a clinic are usually billed with a HCPCS Level II code and reported with their NDC.
- Is a J-code the same as a HCPCS code?A J-code is a HCPCS code: J-codes are the part of HCPCS Level II, J0000 to J9999, that describes drugs, mostly ones given by injection or infusion, plus chemotherapy and some other drugs. Every J-code is a HCPCS code, but most HCPCS codes are not J-codes.
- How do I find the J-code for a drug or an NDC?Search the current HCPCS Level II code set by the drug's generic name, then check that the descriptor matches the drug's form and route. To go from an NDC to a J-code, use a crosswalk such as CMS's quarterly ASP NDC-HCPCS crosswalk, and confirm the match against the descriptor.
- How are J-code billing units calculated?Divide the dose given by the amount in the J-code's descriptor. If the descriptor is "1 mg" and 200 mg was given, report 200 units; if it is "10 mg" and 350 mg was given, report 35. The descriptor amount, not the vial size, sets the unit.
CPT and drug billing
- What is a CPT code?CPT (Current Procedural Terminology) is the American Medical Association's code set for reporting medical, surgical and diagnostic procedures and services. In drug billing, CPT describes the service — giving an injection or infusion — while the drug itself is usually reported with a HCPCS Level II code.
- What is the difference between CPT and HCPCS?HCPCS has two levels. Level I is CPT, maintained by the American Medical Association, for procedures and services. Level II is maintained by CMS and covers products, supplies and services that CPT does not, including drugs in the J range.
- Which codes are used to bill a drug?A clinician-administered drug is usually billed with a HCPCS code for the drug and its units, the drug's NDC with a unit qualifier and quantity, a CPT code for giving it, and a diagnosis code. Hospital claims add a revenue code. Drugs dispensed by a pharmacy are billed by NDC alone.
- Which CPT codes are used to bill giving a drug?Giving a drug is billed separately from the drug itself. The drug goes on its own line with its HCPCS code (often a J-code), units and NDC; the injection or infusion is a CPT code from the drug administration section — 96360–96379 for hydration, therapeutic injections and infusions, 96401–96549 for chemotherapy and other highly complex drugs, and 90460–90474 for vaccines.
- Do Mounjaro and Zepbound have ICD-10 codes?No. ICD-10-CM codes describe diagnoses, not drugs. A prescription for Mounjaro or Zepbound carries the ICD-10-CM code for the condition it treats, chosen from the patient's record; the drug itself is identified by its NDC.