Prescription drug · ANDA

Omeprazole NDC 63187-820

Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-820Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0820Add 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
63187-820-06631870820066 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-06)Marketed from Sep 1, 2019
63187-820-146318708201414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-14)Marketed from Mar 1, 2017
63187-820-206318708202020 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-20)Marketed from Mar 1, 2017
63187-820-306318708203030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-30)Marketed from Mar 1, 2017
63187-820-606318708206060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-60)Marketed from Mar 1, 2017
63187-820-7263187082072120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-72)Marketed from Mar 1, 2017
63187-820-7863187082078180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-78)Marketed from Mar 1, 2017
63187-820-906318708209090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-820-90)Marketed from Mar 1, 2017

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091672
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 63187-820_8d62caf4-32be-4a2c-be08-c70a967ef307SPL ID 8d62caf4-32be-4a2c-be08-c70a967ef307SPL set ID 2d99b4fd-49b3-403d-96a4-0cceda85a95cRxCUI 198051UNII KG60484QX9UPC 0363187820060
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

N463187082006 followed by a unit qualifier and the quantity

Package 63187-0820-06. 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 delayed-release capsules are 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 activ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091672

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

FDA NDC Directory listings under ANDA 091672
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6881
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3007
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-6995
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNuCarePharmaceuticals, Inc.68071-2199
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8079
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-2251
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralUnit Dose Solutions, Inc.87441-063
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5501
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPHOENIX RX LLC85509-1396
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralST. MARY'S MEDICAL PARK PHARMACY60760-841
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-055
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-828
Omeprazole DRomeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0070
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1639
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-501
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-4024
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-280
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-3876
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-942
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5111

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