NDC codes

FDA NDC Directory
Product NDC (as listed)69097-507Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69097-0507Add 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
69097-507-316909705073130 FOR SUSPENSION in 1 CARTON (69097-507-31)Marketed from Jan 7, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Esomeprazole magnesium
Generic name (nonproprietary)
esomeprazole magnesium
Active ingredients
Esomeprazole magnesium dihydrate — 2.5 mg/1
Dosage form
For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217714
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 69097-507_75c5150c-7eab-4f85-9c34-80c0ecb4a07bSPL ID 75c5150c-7eab-4f85-9c34-80c0ecb4a07bSPL set ID e89589f1-945e-429a-819e-61755cba77faRxCUI 1297658, 1297761UNII 36H71644EQ
Pharmacologic class
Proton Pump 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

N469097050731 followed by a unit qualifier and the quantity

Package 69097-0507-31. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 217714

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

FDA NDC Directory listings under ANDA 217714
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole magnesiumEsomeprazole magnesium dihydrate 5 mg/1For suspensionOralCipla USA Inc.69097-508

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