Prescription drug · ANDA

Omeprazole NDC 82804-280

Omeprazole 10 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)82804-280Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0280Add 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 NDC11-digit (billing)PackageCopy
82804-280-608280402806060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-280-60)Marketed from Apr 16, 2026

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)
Omeprazole
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole — 10 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203270
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 82804-280_61eab342-61fd-471f-8f70-95f9cbca0097SPL ID 61eab342-61fd-471f-8f70-95f9cbca0097SPL set ID 61eab342-61fd-471f-8f70-95f9cbca0097RxCUI 199119UNII KG60484QX9UPC 0382804280605
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

N482804028060 followed by a unit qualifier and the quantity

Package 82804-0280-60. 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 .

Indications (excerpt from the label)

Omeprazole is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults ( 1.1 ) • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) • Treatment of active benign gastric ulcer in adults ( 1.3 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) • Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) • Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203270

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

FDA NDC Directory listings under ANDA 203270
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7366
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7367
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralQPharma Inc42708-199
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1852
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1851
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-2262
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC82868-043
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-001
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-002
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-003
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7213
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7214
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7215
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Phharmaceuticals Inc.68788-4104
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.57237-160
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.57237-161
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.57237-162
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack72162-2388
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC51655-452
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralQPharma, Inc.42708-159

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