Esomeprazole Magnesium NDC 68382-849

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-849Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0849Add 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
68382-849-94	68382084994	30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94)Marketed from Jun 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 magnesium dihydrate — 40 mg/1
Dosage form: Granule, Delayed release
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206055
Marketing start: Jun 30, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 68382-849_bc31956a-671b-4ca3-b9dd-1fdb03003caeSPL ID bc31956a-671b-4ca3-b9dd-1fdb03003caeSPL set ID 190a4c5b-1547-45d7-b00b-10da4131e2e2RxCUI 692576, 692578UNII 36H71644EQ
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

N468382084994 followed by a unit qualifier and the quantity

Package 68382-0849-94. 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 Aug 17, 2023.

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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206055

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

FDA NDC Directory listings under ANDA 206055
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Granule, Delayed releaseOral	Zydus Pharmaceuticals USA Inc.	68382-848
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Granule, Delayed releaseOral	Zydus Lifesciences Limited	70771-1391
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 40 mg/1	Granule, Delayed releaseOral	Zydus Lifesciences Limited	70771-1392