Prescription drug · ANDA

Omeprazole NDC 51655-452

Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Northwind Health Company, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)51655-452Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0452Add 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
51655-452-255165504522560 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-452-25)Marketed from Feb 2, 2023
51655-452-265165504522690 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-452-26)Marketed from Sep 26, 2022

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 — 40 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 51655-452_4b44baf6-9a17-c928-e063-6294a90a884eSPL ID 4b44baf6-9a17-c928-e063-6294a90a884eSPL set ID f3038133-8bb2-044e-e053-2995a90a6e7dRxCUI 200329UNII KG60484QX9
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

N451655045225 followed by a unit qualifier and the quantity

Package 51655-0452-25. 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. Most patie…

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 releaseOralProficient Rx LP82804-280
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 releaseOralQPharma, Inc.42708-159

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