NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1395Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1395Add 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
71335-1395-17133513950160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-1)Marketed from Feb 1, 2012
71335-1395-27133513950230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-2)Marketed from Feb 1, 2012
71335-1395-37133513950320 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-3)Marketed from Feb 1, 2012
71335-1395-47133513950490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-4)Marketed from Feb 1, 2012
71335-1395-57133513950514 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-5)Marketed from Feb 1, 2012
71335-1395-671335139506120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-6)Marketed from Feb 1, 2012
71335-1395-771335139507100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-7)Marketed from Feb 1, 2012
71335-1395-871335139508180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-8)Marketed from Feb 1, 2012

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 076048
Marketing start
Marketing end
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 71335-1395_f5868802-1b1f-4d48-8793-39d25a65b0d8SPL ID f5868802-1b1f-4d48-8793-39d25a65b0d8SPL set ID 44349466-73ea-4053-8ff6-5b4b7372c9cdRxCUI 198051, 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

N471335139501 followed by a unit qualifier and the quantity

Package 71335-1395-01. 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 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older ( 1.5 ) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole del…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076048

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

FDA NDC Directory listings under ANDA 076048
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-170
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralApotex Corp60505-3952
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0569
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-248
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralApotex Corp60505-0065
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1636
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-061
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralApotex Corp60505-0145
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralApotex Corp60505-0146
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-070

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