NDC codes

FDA NDC Directory
Product NDC (as listed)43547-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0001Add 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
43547-001-034354700010330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-03)Marketed from Mar 28, 2023
43547-001-094354700010990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-09)Marketed from Mar 28, 2023

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 trihydrate — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214920
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 43547-001_3d2a1a0f-c770-4f46-851e-0697e4f5de4cSPL ID 3d2a1a0f-c770-4f46-851e-0697e4f5de4cSPL set ID 3cd80c04-43a2-4be3-b831-ebccc273a0d2RxCUI 606726, 606730UNII R6DXU4WAY9UPC 0343547001032, 0343547002039
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

N443547000103 followed by a unit qualifier and the quantity

Package 43547-0001-03. 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

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