Over-the-counter drug · NDA

topcare omeprazole (Omeprazole) NDC 76162-470

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

NDC codes

FDA NDC Directory
Product NDC (as listed)76162-470Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76162-0470Add 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
76162-470-0176162047001761620470011 BOTTLE in 1 CARTON (76162-470-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2022
76162-470-0376162047003761620470033 BOTTLE in 1 CARTON (76162-470-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2022

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
Labeler
Topco Associates LLCNDC labeler code 76162
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 76162-470_255def35-0ba3-44c0-af0c-e5aa99806996SPL ID 255def35-0ba3-44c0-af0c-e5aa99806996SPL set ID ec9d8dab-480c-49bc-bdbb-bebcc7676d01RxCUI 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

N476162047001 followed by a unit qualifier and the quantity

Package 76162-0470-01. 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)

About NDC 76162-470

What is NDC 76162-470?
76162-470 is the product NDC for topcare omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
topcare omeprazole (Omeprazole).
What is the active ingredient?
Omeprazole.
Who is the labeler?
Topco Associates LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for topcare omeprazole?
2 other product NDCs are listed under this name. See all topcare 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 topcare omeprazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
topcare omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralTopco Associates LLC36800-60136800-0601-55
TopCare OmeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralTopco Associates LLC36800-91536800-0915-0136800-0915-0336800-0915-30+2 more

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
24 hr omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralMeijer, Inc.79481-0075
basic care omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-047
basic care omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-401
basic care omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-915
Berkley and Jensen OmeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralBJWC68391-915
care one omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmerican Sales Company41520-915
careone omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmerican Sales Company41520-802
careone omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralRetail Business Services, LLC72476-473
dg health omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDolgencorp Inc55910-215
dg health omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDolgencorp Inc55910-712
dg health omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDolgencorp, LLC55910-915
equaline omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralUnited Natural Foods, Inc. dba UNFI41163-915
equate omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralWal-Mart Stores Inc49035-119
equate omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralWALMART INC.79903-113
Equate omeprazole delayed release acid reduceromeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralWal-Mart Stores Inc49035-915
exchange select omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralArmy & Air Force Exchange Service55301-915
foster and thrive omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1104
foster and thrive omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralStrategic Sourcing Services LLC70677-1275
good neighbor pharmacy omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmerisource Bergen46122-029
good neighbor pharmacy omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmerisource Bergen46122-281

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