NDC codes

FDA NDC Directory
Product NDC (as listed)82009-022Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0022Add 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
82009-022-1082009002210820090022101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-022-10)Marketed from Nov 15, 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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075576
Marketing start
Marketing end
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 82009-022_17380ad5-9506-8e44-aa84-b6ce52ac7b9bSPL ID 17380ad5-9506-8e44-aa84-b6ce52ac7b9bSPL set ID 665e9877-85ac-fdb6-54ac-1c47941ceab8RxCUI 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

N482009002210 followed by a unit qualifier and the quantity

Package 82009-0022-10. 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)

About NDC 82009-022

What is NDC 82009-022?
82009-022 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, 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?
Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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 075576

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

FDA NDC Directory listings under ANDA 075576
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-805
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralQPharma, Inc.42708-158
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralNorthStar Rx LLC16714-714
Omeprazole DRomeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0071
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0415
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralQuality Care Products, LLC49999-265
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC51655-061
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0332
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Limited55111-158
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Limited55111-157
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Limited55111-159
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-1157
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-833
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.43063-743

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