Esomeprazole Magnesium NDC 0378-2351

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-2351Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-2351Add 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
0378-2351-77	00378235177	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-77)Marketed from Dec 7, 2015
0378-2351-93	00378235193	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2351-93)Marketed from Aug 3, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078936
Marketing start: Aug 3, 2015
Marketing end: Mar 31, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0378-2351_76a5be72-e454-42c0-84b4-ed818a559c79SPL ID 76a5be72-e454-42c0-84b4-ed818a559c79SPL set ID e04e7c84-59c8-4a1d-8dfc-d72588b97b59RxCUI 606726, 606730UNII R6DXU4WAY9UPC 0303782350937, 0303782351934
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

N400378235177 followed by a unit qualifier and the quantity

Package 00378-2351-77. 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 Nov 15, 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 with 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.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078936

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

FDA NDC Directory listings under ANDA 078936
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed release pelletsOral	Mylan Pharmaceuticals Inc.	0378-2350