Prescription drug · ANDA

Omeprazole NDC 59651-002

Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Aurobindo Pharma Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)59651-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0002Add 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
59651-002-0159651000201100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-01)Marketed from Aug 19, 2015
59651-002-03596510002033 BLISTER PACK in 1 CARTON (59651-002-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10)Marketed from Aug 19, 2015
59651-002-0559651000205500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-05)Marketed from Aug 19, 2015
59651-002-305965100023030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-30)Marketed from Aug 19, 2015
59651-002-785965100027810 BLISTER PACK in 1 CARTON (59651-002-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10)Marketed from Aug 19, 2015
59651-002-905965100029090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-90)Marketed from Aug 19, 2015
59651-002-99596510002991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-002-99)Marketed from Aug 19, 2015

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
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203270
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 59651-002_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27aSPL ID 4cc78adf-d6a3-47b6-bc25-9d3f28d2a27aSPL set ID 934601b6-fbba-43c4-a8ef-7a7dfe9f9a51RxCUI 198051, 199119, 200329UNII KG60484QX9UPC 0359651001301, 0359651002308, 0359651003305
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

N459651000201 followed by a unit qualifier and the quantity

Package 59651-0002-01. 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 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 59651-002

What is NDC 59651-002?
59651-002 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Aurobindo Pharma Limited. It has 7 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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?
249 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 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-66672288-0666-55
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDiscount Drug Mart, Inc53943-03853943-0038-1453943-0038-42
Omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-01573581-0015-03
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
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-409900363-4099-03

All 250 Omeprazole NDCs

Other NDCs under ANDA 203270

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

FDA NDC Directory listings under ANDA 203270
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralQPharma, Inc.42708-159
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralQPharma Inc42708-199
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7213
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7214
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7215
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7366
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7367
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC51655-452
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.57237-160
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.57237-161
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.57237-162
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-001
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-003
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-2262
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Phharmaceuticals Inc.68788-4104
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1851
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1852
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack72162-2388
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP82804-280
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNorthwind Health Company, LLC82868-043

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