ezetimibe NDC 70771-1109

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1109Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1109Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
70771-1109-0	70771110900	1000 TABLET in 1 BOTTLE (70771-1109-0)Marketed from Aug 9, 2017
70771-1109-1	70771110901	100 TABLET in 1 BOTTLE (70771-1109-1)Marketed from Aug 9, 2017
70771-1109-3	70771110903	30 TABLET in 1 BOTTLE (70771-1109-3)Marketed from Aug 9, 2017
70771-1109-4	70771110904	10 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2)Marketed from Aug 9, 2017
70771-1109-5	70771110905	500 TABLET in 1 BOTTLE (70771-1109-5)Marketed from Aug 9, 2017
70771-1109-9	70771110909	90 TABLET in 1 BOTTLE (70771-1109-9)Marketed from Aug 9, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): ezetimibe
Generic name (nonproprietary): ezetimibe
Active ingredients: Ezetimibe — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204331
Marketing start: Aug 9, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)
Identifiers: Product ID 70771-1109_5862da1c-e73d-44ff-a961-aaef469ed646SPL ID 5862da1c-e73d-44ff-a961-aaef469ed646SPL set ID de814dcd-4759-4e9c-a650-335fb885a79dRxCUI 349556UNII EOR26LQQ24
Pharmacologic class: Dietary Cholesterol Absorption Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470771110900 followed by a unit qualifier and the quantity

Package 70771-1109-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 28, 2024.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204331

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204331
Product	Strength	Form · route	Labeler	Product NDC
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-773
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-024
ezetimibe	Ezetimibe 10 mg/1	TabletOral	Safecor Health, LLC	48433-161