NDC codes

FDA NDC Directory
Product NDC (as listed)65841-760Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0760Add 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
65841-760-016584107600165841076001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-01)Marketed from Nov 23, 2012
65841-760-056584107600565841076005500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-05)Marketed from Nov 23, 2012
65841-760-06658410760066584107600630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-06)Marketed from Nov 23, 2012
65841-760-1065841076010658410760101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-10)Marketed from Nov 23, 2012
65841-760-16658410760166584107601690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-16)Marketed from Nov 23, 2012

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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 65841
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091352
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 65841-760_691b64ae-e6ff-4a10-9973-886901529db0SPL ID 691b64ae-e6ff-4a10-9973-886901529db0SPL set ID 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2RxCUI 198051, 199119, 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

N465841076001 followed by a unit qualifier and the quantity

Package 65841-0760-01. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 65841-760

What is NDC 65841-760?
65841-760 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Zydus Lifesciences Limited. It has 5 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?
Zydus Lifesciences Limited, NDC labeler code 65841. 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 091352

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

FDA NDC Directory listings under ANDA 091352
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralMajor Pharmaceuticals0904-6917
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7018
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7019
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7021
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralCardinal Health 107, LLC55154-2332
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralZydus Lifesciences Limited65841-759
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralZydus Lifesciences Limited65841-761
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralZydus Pharmaceuticals USA Inc.68382-411
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralZydus Pharmaceuticals USA Inc.68382-412
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralZydus Pharmaceuticals USA Inc.68382-500
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-9744

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