What is the NDC number on eye drops?

The NDC, or National Drug Code, is the FDA’s identifier for a drug product. It’s a 10-digit number in three segments: the labeler (the company), the product (its strength, form and formulation) and the package (size and type). When a company prints it on a box or bottle, it usually appears with the letters “NDC” in front. It identifies a product; it isn’t a sign of FDA approval.

What NDC stands for

National Drug Code. The FDA describes it as a unique, three-segment number that serves as the agency’s identifier for drugs. Companies that make, repackage or distribute drugs under their own name list their products with the FDA using these numbers, and the FDA publishes them in its NDC Directory.

How to read the three segments

According to the FDA’s background page on the NDC, each segment has a job, and they aren’t all assigned by the same party:

• Labeler code: the first segment, assigned by the FDA. It identifies the firm that makes, repackages or distributes the drug under its own name.
• Product code: the second segment, assigned by the firm. It identifies a specific strength, dosage form and formulation from that firm.
• Package code: the third segment, also assigned by the firm. It identifies package sizes and types.

Because the whole number is 10 digits, the segments come in one of three patterns: 4-4-2, 5-3-2 or 5-4-1. Written with the dashes, an NDC might look like XXXXX-XXX-XX. That’s why two NDCs from different companies can have differently sized segments, and why the dashes matter when you read one out to a pharmacist. Some computer systems add a leading zero to make every NDC the same length, which can make the original hard to reconstruct.

Where is the NDC number on eye drops?

There isn’t one fixed spot. When a company prints an NDC, look for the letters “NDC” followed by the number on the outer carton, often on the front or a side panel, and sometimes on the bottle label too. It’s a separate number from the lot number and the expiration date, which are usually stamped or printed together on a flap or the bottom of the box.

This site doesn’t publish an NDC for Quell. If you need one for a form or a question, check the carton you have, or call Quell at 615.465.6041, M–F 9AM–5PM CST.

How to look up an NDC

• Search “FDA NDC Directory” and open the FDA’s own search page.
• Enter the number with or without dashes, or search by product or company name.
• Check the listing’s proprietary name, labeler, dosage form and package description against the box in your hand.
• Keep in mind that the directory is updated daily, and a very new or recently changed listing may differ from an older box.

Does an NDC number mean a drug has FDA approval?

No. The FDA says plainly that assigning an NDC doesn’t in any way denote approval of the product, and that inclusion in the NDC Directory doesn’t mean the FDA has verified the information. The directory covers prescription and over-the-counter drugs, approved and unapproved, along with repackaged and relabeled products. Over-the-counter eye drops like Quell are marketed under FDA’s monograph rules for that category rather than individual approval, and an NDC doesn’t change that.

NDC vs. lot number, expiration date and barcode

• NDC: identifies the product and package. Every box of the same product and package size carries the same one.
• Lot number: identifies a production batch, which matters for recalls. See what the lot number means.
• Expiration date: the date to use it by. See where the expiration date is.
• Barcode: the scannable retail code a store’s register reads. It’s a separate system from the NDC, even when the two share digits.

When you might need the NDC

Most people never do. It comes up when a pharmacist is checking exactly which product you used, when you report a problem to the FDA through MedWatch, or when a form asks for it. In each case, read it straight from the box, dashes included, rather than from memory.

The coming change to 12 digits

The FDA has adopted a uniform 12-digit format for the NDC through a final rule, effective March 7, 2033. Until then, boxes on shelves and in medicine cabinets will carry the 10-digit form described above. How to read an eye drop Drug Facts label covers the rest of what’s printed on the carton.