Over-the-counter drug · NDA

TopCare Omeprazole (omeprazole) NDC 36800-915

Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-915Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0915Add 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
36800-915-01368000915011 BOTTLE in 1 CARTON (36800-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Oct 11, 2010
36800-915-03368000915033 BOTTLE in 1 CARTON (36800-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Dec 28, 2011
36800-915-30368000915302 CARTON in 1 CARTON (36800-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 29, 2008
36800-915-55368000915553 CARTON in 1 CARTON (36800-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 29, 2008
36800-915-743680009157414 BLISTER PACK in 1 CARTON (36800-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 29, 2008

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)
TopCare Omeprazole
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022032
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 36800-915_e1557259-5889-4677-981e-ebd3970162c8SPL ID e1557259-5889-4677-981e-ebd3970162c8SPL set ID 4d98665d-38db-4c08-8406-cc0e45f7ab7cRxCUI 402014UNII 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

N436800091501 followed by a unit qualifier and the quantity

Package 36800-0915-01. 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)

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022032

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

FDA NDC Directory listings under NDA 022032
ProductStrengthForm · routeLabelerProduct NDC
Good Sense OmeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralL. Perrigo Company0113-0915
foster and thrive omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1275
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralPadagis Israel Pharmaceuticals Ltd45802-888
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralHyVee Inc42507-414
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralWalgreen Company0363-0007
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralH E B37808-401
basic care omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-047
careone omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralRetail Business Services, LLC72476-473
Good Sense OmeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralL. Perrigo Company0113-1723
exchange select omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralArmy & Air Force Exchange Service55301-915
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralH E B59640-047
careone omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmerican Sales Company41520-802
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralRite Aid Corporation11822-0453
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralCVS Pharmacy59779-503
good sense omeprazole delayed releaseomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralL. Perrigo Company0113-1803
good now omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralGobrands, Inc82501-0915
kirkland signature omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralCostco Wholesale Company63981-915
foster and thrive omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1104
omeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralHyVee Inc42507-915
good neighbor pharmacy omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmerisource Bergen46122-029

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