NDC codes

FDA NDC Directory
Product NDC (as listed)63187-805Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0805Add 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
63187-805-60631870805606318708056060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-60)Marketed from Jan 2, 2017
63187-805-90631870805906318708059090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-805-90)Marketed from Jan 2, 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 — 10 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075576
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 63187-805_cc7a83fe-a933-4a9a-b6ac-a2b1d85cdeb1SPL ID cc7a83fe-a933-4a9a-b6ac-a2b1d85cdeb1SPL set ID f0f61a89-700d-481d-9255-6f9a9afa7025RxCUI 199119UNII KG60484QX9UPC 0363187805609
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

N463187080560 followed by a unit qualifier and the quantity

Package 63187-0805-60. 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: 1. Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2) 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 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, in combination with clarithromycin and amoxic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-805

What is NDC 63187-805?
63187-805 is the product NDC for Omeprazole, Omeprazole 10 mg/1 capsule, delayed release, listed with the FDA by Proficient Rx LP. It has 2 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?
Proficient Rx LP, NDC labeler code 63187. 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 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 releaseOralQuallent Pharmaceuticals Health LLC82009-022
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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