What is NDC 68382-441?

68382-441 is the product NDC for esomeprazole magnesium, Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Esomeprazole magnesium dihydrate.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for esomeprazole magnesium?

174 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

esomeprazole magnesium NDC 68382-441 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-441Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0441Add 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
68382-441-06	68382044106	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-441-06)Marketed from May 30, 2019
68382-441-10	68382044110	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-441-10)Marketed from May 30, 2019
68382-441-16	68382044116	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-441-16)Marketed from May 30, 2019

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 — 20 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206296
Marketing start: May 30, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 68382-441_5d33bc3b-4750-4fd3-99b5-f70a1520c32cSPL ID 5d33bc3b-4750-4fd3-99b5-f70a1520c32cSPL set ID c4b0571e-7b09-441b-90be-bc653806812bRxCUI 606726, 606730UNII 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

N468382044106 followed by a unit qualifier and the quantity

Package 68382-0441-06. 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 11, 2024.

Indications (excerpt from the label)

Esomeprazole magnesium delayed-release capsules are 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. ( 1.4 ) Helico…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-441

What is NDC 68382-441?: 68382-441 is the product NDC for esomeprazole magnesium, Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: esomeprazole magnesium.
What is the active ingredient?: Esomeprazole magnesium dihydrate.
Who is the labeler?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for esomeprazole magnesium?: 174 other product NDCs are listed under this name. See all esomeprazole magnesium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other esomeprazole magnesium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	St. Mary's Medical Park Pharmacy	60760-877	60760-0877-60
Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-563	72288-0563-01
esomeprazole magnesiumesomeprazole magnesium dihydrate	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-780	72288-0780-03
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	American Health Packaging	60687-934	60687-0934-21
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-669	72288-0669-0172288-0669-03
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	H-E-B	37808-646	37808-0646-4137808-0646-4537808-0646-82
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Rising Pharma Holdings, Inc.	64980-664	64980-0664-1964980-0664-41
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	CapsuleOral	YYBA CORP	73581-014	73581-0014-42
Esomeprazole Magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	AvPAK	50268-272	50268-0272-13
Esomeprazole Magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-4581	70518-4581-00

All 175 esomeprazole magnesium NDCs

Other NDCs under ANDA 206296

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

FDA NDC Directory listings under ANDA 206296
Product	Strength	Form · route	Labeler	Product NDC
esomeprazole magnesium	Esomeprazole magnesium dihydrate 40 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1335
esomeprazole magnesium	Esomeprazole magnesium dihydrate 40 mg/1	Capsule, Delayed releaseOral	Zydus Pharmaceuticals USA Inc.	68382-442
esomeprazole magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1368
esomeprazole magnesium	Esomeprazole magnesium dihydrate 40 mg/1	Capsule, Delayed releaseOral	Zydus Lifesciences Limited	70771-1494
esomeprazole magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Zydus Lifesciences Limited	70771-1493