NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1636Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1636Add 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
71335-1636-071335163600713351636007 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-0)Marketed from Oct 31, 2024
71335-1636-1713351636017133516360130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-1)Marketed from Oct 31, 2024
71335-1636-2713351636027133516360260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-2)Marketed from Oct 31, 2024
71335-1636-3713351636037133516360356 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-3)Marketed from Oct 31, 2024
71335-1636-4713351636047133516360490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-4)Marketed from Oct 31, 2024
71335-1636-5713351636057133516360520 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-5)Marketed from Oct 31, 2024
71335-1636-6713351636067133516360615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-6)Marketed from Oct 31, 2024
71335-1636-77133516360771335163607120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-7)Marketed from Oct 31, 2024
71335-1636-87133516360871335163608100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-8)Marketed from Oct 31, 2024
71335-1636-9713351636097133516360928 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1636-9)Marketed from Oct 31, 2024

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 71335-1636_edbe8fe0-7fe4-4a6a-b857-622b98fc85a1SPL ID edbe8fe0-7fe4-4a6a-b857-622b98fc85a1SPL set ID 1249c42d-6358-48b3-8fe0-10333c7f501dRxCUI 198051UNII 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

N471335163600 followed by a unit qualifier and the quantity

Package 71335-1636-00. 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 71335-1636

What is NDC 71335-1636?
71335-1636 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 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0569
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1395
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-248

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