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 NDC11-digit (billing)PackageCopy
70771-1109-070771110900707711109001000 TABLET in 1 BOTTLE (70771-1109-0)Marketed from Aug 9, 2017
70771-1109-17077111090170771110901100 TABLET in 1 BOTTLE (70771-1109-1)Marketed from Aug 9, 2017
70771-1109-3707711109037077111090330 TABLET in 1 BOTTLE (70771-1109-3)Marketed from Aug 9, 2017
70771-1109-4707711109047077111090410 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2)Marketed from Aug 9, 2017
70771-1109-57077111090570771110905500 TABLET in 1 BOTTLE (70771-1109-5)Marketed from Aug 9, 2017
70771-1109-9707711109097077111090990 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 LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204331
Marketing start
Listing expires
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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1109

What is NDC 70771-1109?
70771-1109 is the product NDC for ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ezetimibe.
What is the active ingredient?
Ezetimibe.
Who is the labeler?
Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ezetimibe?
40 other product NDCs are listed under this name. See all ezetimibe NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other ezetimibe NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ezetimibeEzetimibe 10 mg/1TabletOralSafecor Health, LLC48433-16148433-0161-03
EzetimibeEzetimibe 10 mg/1TabletOralMacleods Pharmaceuticals Limited33342-37333342-0373-0733342-0373-1033342-0373-15
EzetimibeEzetimibe 10 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-78710135-0787-0510135-0787-3010135-0787-90
ezetimibeEzetimibe 10 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-02482009-0024-05
EzetimibeEzetimibe 10 mg/1TabletOralCamber Pharmaceuticals, Inc.31722-62831722-0628-0131722-0628-0531722-0628-10+4 more
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-768950090-7689-00
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-769050090-7690-0050090-7690-01
EzetimibeEzetimibe 10 mg/1TabletOralBryant Ranch Prepack71335-309271335-3092-0171335-3092-0271335-3092-03+2 more
EzetimibeEzetimibe 10 mg/1TabletOralOrient Pharma Co., Ltd.76333-17076333-0170-1276333-0170-1376333-0170-14+1 more
EzetimibeEzetimibe 10 mg/1TabletOralA-S Medication Solutions50090-733850090-7338-00

All 41 ezetimibe NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
ezetimibeEzetimibe 10 mg/1TabletOralSafecor Health, LLC48433-161
ezetimibeEzetimibe 10 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-773
ezetimibeEzetimibe 10 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-024

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