Esomeprazole Magnesium NDC 69097-527

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-527Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0527Add 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	Copy
69097-527-34	69097052734	30 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34)Marketed from Mar 24, 2020

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 — 10 mg/1
Dosage form: Granule, For suspension, Extended release
Route: Oral
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211752
Marketing start: Mar 24, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 69097-527_95dea6c3-8880-42b2-a2d4-8cf93629127eSPL ID 95dea6c3-8880-42b2-a2d4-8cf93629127eSPL set ID 180490d1-c165-4bb9-96b1-12e727256e4eRxCUI 861568UNII 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

N469097052734 followed by a unit qualifier and the quantity

Package 69097-0527-34. 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 May 16, 2024.

Indications (excerpt from the label)

Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year to 17 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 1 year to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for develo…

Excerpt only. Read the full label for complete information.

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