What is NDC 82804-078?

82804-078 is the product NDC for esomeprazole magnesium, Esomeprazole magnesium 40 mg/1 capsule, delayed release, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 82804. 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 82804-078 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-078Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0078Add 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
82804-078-30	82804007830	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-30)Marketed from Feb 28, 2024
82804-078-60	82804007860	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-60)Marketed from Feb 28, 2024
82804-078-90	82804007890	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-90)Marketed from Feb 28, 2024

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
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213486
Marketing start: Mar 19, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 82804-078_7b92ac4f-50c9-4061-b4a7-535a58cea8f6SPL ID 7b92ac4f-50c9-4061-b4a7-535a58cea8f6SPL set ID 7b92ac4f-50c9-4061-b4a7-535a58cea8f6RxCUI 606730UNII R6DXU4WAY9UPC 0382804078301
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

N482804007830 followed by a unit qualifier and the quantity

Package 82804-0078-30. 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 Feb 1, 2024.

Indications (excerpt from the label)

Esomeprazole is 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. ( 1.4 ) • Helicobacter pylori eradicatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-078

What is NDC 82804-078?: 82804-078 is the product NDC for esomeprazole magnesium, Esomeprazole magnesium 40 mg/1 capsule, delayed release, listed with the FDA by Proficient Rx LP. 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.
Who is the labeler?: Proficient Rx LP, NDC labeler code 82804. 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 213486

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

FDA NDC Directory listings under ANDA 213486
Product	Strength	Form · route	Labeler	Product NDC
esomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	NuCare Pharmaceuticals,Inc.	68071-3419
esomeprazole magnesium	Esomeprazole magnesium trihydrate 40 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-8524
esomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Biocon Pharma Inc.,	70377-055
esomeprazole magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	Biocon Pharma Inc.,	70377-056
esomeprazole magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-3850
esomeprazole magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-2476
esomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-9713
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Quallent Pharmaceuticals Health LLC	82009-033
Esomeprazole Magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	Quallent Pharmaceuticals Health LLC	82009-034