NDC codes

FDA NDC Directory
Product NDC (as listed)43598-069Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0069Add 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
43598-069-42435980069423 BOTTLE in 1 CARTON (43598-069-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Dec 30, 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 magnesium20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211571
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 43598-069_16343b5c-975f-5a9b-901b-2a0f26649e80SPL ID 16343b5c-975f-5a9b-901b-2a0f26649e80SPL set ID b9605af1-a117-2fea-9f4b-bd4816d804e2RxCUI 433733UNII R6DXU4WAY9
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

N443598006942 followed by a unit qualifier and the quantity

Package 43598-0069-42. 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 .

Indications (excerpt from the label)

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211571

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

FDA NDC Directory listings under ANDA 211571
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralWalgreens0363-1353
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralDr. Reddys Laboratories Inc75907-119
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Tablet, Delayed releaseOralCVS Pharmacy51316-563

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