NDC codes

FDA NDC Directory
Product NDC (as listed)63187-070Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0070Add 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
63187-070-146318700701414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-070-14)Marketed from Nov 1, 2018
63187-070-306318700703030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-070-30)Marketed from Nov 1, 2018
63187-070-606318700706060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-070-60)Marketed from Nov 1, 2018
63187-070-7263187007072120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-070-72)Marketed from Nov 1, 2018
63187-070-7863187007078180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-070-78)Marketed from Nov 1, 2018
63187-070-906318700709090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-070-90)Marketed from Nov 1, 2018

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
Omeprazole20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
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 63187-070_0cc267bf-8650-40e3-a05d-e102e275c4c2SPL ID 0cc267bf-8650-40e3-a05d-e102e275c4c2SPL set ID 03ac077f-3873-4087-96d0-89049161dea9RxCUI 198051, 199119UNII KG60484QX9UPC 0363187061609, 0363187070304
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

N463187007014 followed by a unit qualifier and the quantity

Package 63187-0070-14. 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 indicated for: • Treatment in adults of duodenal ulcer ( 1.1 ) and gastric ulcer ( 1.2 ) • Treatment in adults and children of gastroesophageal reflux disease (GERD) ( 1.3 ) and maintenance of healing of erosive esophagitis ( 1.4 ) The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. ( 8.4 ) 1.1 Duodenal Ulcer (adults) Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole delayed-release capsules, USP, in combination with clarithr

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1395
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralApotex Corp60505-3952
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0569
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-248
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1636
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralApotex Corp60505-0065
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-061
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralApotex Corp60505-0146
OmeprazoleOmeprazole 10 mg/1Capsule, Delayed releaseOralApotex Corp60505-0145
OmeprazoleOmeprazole 40 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-170

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