NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0569Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0569Add 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
71335-0569-071335056900713350569007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-0)Marketed from Jun 26, 2006
71335-0569-1713350569017133505690130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-1)Marketed from Jun 26, 2006
71335-0569-2713350569027133505690260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-2)Marketed from Jun 26, 2006
71335-0569-3713350569037133505690356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-3)Marketed from Jun 26, 2006
71335-0569-4713350569047133505690490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-4)Marketed from Jun 26, 2006
71335-0569-5713350569057133505690520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-5)Marketed from Jun 26, 2006
71335-0569-6713350569067133505690615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-6)Marketed from Jun 26, 2006
71335-0569-77133505690771335056907120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-7)Marketed from Jun 26, 2006
71335-0569-87133505690871335056908100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-8)Marketed from Jun 26, 2006
71335-0569-9713350569097133505690928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0569-9)Marketed from Jun 26, 2006

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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-0569_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

N471335056900 followed by a unit qualifier and the quantity

Package 71335-0569-00. 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)

About NDC 71335-0569

What is NDC 71335-0569?
71335-0569 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Omeprazole.
What is the active ingredient?
Omeprazole.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Omeprazole?
252 other product NDCs are listed under this name. See all Omeprazole 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 Omeprazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association, Inc.83324-30983324-0309-1483324-0309-42
OmeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-66672288-0666-5572288-0666-74
Omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-01573581-0015-03
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDiscount Drug Mart, Inc53943-03853943-0038-1453943-0038-42
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-93472288-0934-01
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralH E B59640-69959640-0699-0159640-0699-03
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralUnit Dose Solutions, Inc.87441-06387441-0063-01
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway21130-78321130-0783-0121130-0783-03
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Phharmaceuticals Inc.68788-410468788-4104-0168788-4104-0268788-4104-03+4 more
omeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-60672288-0606-03

All 253 Omeprazole NDCs

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 20 mg/1Capsule, Delayed releaseOralApotex Corp60505-0065
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralApotex Corp60505-0145
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralApotex Corp60505-0146
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralApotex Corp60505-3952
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-061
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-070
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-170
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1395
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1636
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-248

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