Esomeprazole Magnesium NDC 16571-880

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-880Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0880Add 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
16571-880-42	16571088042	3 BOTTLE in 1 CARTON (16571-880-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Dec 1, 2022

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 — 20 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216349
Marketing start: Dec 1, 2022
Marketing end: May 11, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 16571-880_c2ecacac-d8da-43fc-81c6-7db66f837d69SPL ID c2ecacac-d8da-43fc-81c6-7db66f837d69
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

N416571088042 followed by a unit qualifier and the quantity

Package 16571-0880-42. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 216349

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

FDA NDC Directory listings under ANDA 216349
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Rising Pharma Holdings, Inc.	64980-664
esomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	GLENMARK THERAPEUTICS INC., USA	72657-124
esomeprazole magnesium	Esomeprazole magnesium trihydrate 20 mg/1	Capsule, Delayed releaseOral	GLENMARK THERAPEUTICS INC., USA	72657-127
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Reliable 1 Laboratories LLC	69618-073