Esomeprazole Magnesium NDC 68462-391

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-391Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0391Add 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
68462-391-10	68462039110	1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-10)Marketed from Nov 1, 2021
68462-391-30	68462039130	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-30)Marketed from Nov 1, 2021
68462-391-90	68462039190	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-90)Marketed from Nov 1, 2021

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 — 40 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209495
Marketing start: Nov 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 68462-391_5eef4592-c7ef-454c-88a9-62671fff9088SPL ID 5eef4592-c7ef-454c-88a9-62671fff9088SPL set ID a6430045-ae60-4a16-92b9-2975cb497629RxCUI 606726, 606730UNII R6DXU4WAY9UPC 0368462391303, 0368462390306
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

N468462039110 followed by a unit qualifier and the quantity

Package 68462-0391-10. 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 Dec 7, 2023.

Indications (excerpt from the label)

Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years 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 12 years to 17 years of age. ( 1.3 ) • Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209495

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

FDA NDC Directory listings under ANDA 209495
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole Magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed release pelletsOral	A-S Medication Solutions	50090-6128
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed release pelletsOral	A-S Medication Solutions	50090-6213
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed release pelletsOral	Glenmark Pharmaceuticals Inc., USA	68462-390