Over-the-counter drug · NDA

Signature Care Omeprazole (omeprazole) NDC 21130-128

Omeprazole 20 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · Safeway

NDC codes

FDA NDC Directory
Product NDC (as listed)21130-128Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21130-0128Add 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
21130-128-55211300128553 CARTON in 1 CARTON (21130-128-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jul 11, 2018
21130-128-742113001287414 BLISTER PACK in 1 CARTON (21130-128-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jul 2, 2020

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)
Signature Care Omeprazole
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole — 20 mg/1
Dosage form
Tablet, Orally disintegrating, Delayed release
Route
Oral
Labeler
Safeway
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 209400
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 21130-128_eb0dd73c-7d2d-424f-a939-dcdb18ee21f1SPL ID eb0dd73c-7d2d-424f-a939-dcdb18ee21f1SPL set ID c76c4235-92d4-4384-8ddc-ceed0b928c48RxCUI 2003656UNII 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

N421130012855 followed by a unit qualifier and the quantity

Package 21130-0128-55. 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 209400

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

FDA NDC Directory listings under NDA 209400
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralCVS Pharmacy69842-791
OmeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-666
omeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralH E B37808-354
Basic Care OmeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-123
topcare omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralTopco Associates LLC36800-601
careone omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmerican Sales Company41520-939
OmeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralMeijer Distribution Inc41250-349
DG health omperazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralDolgencorp Inc55910-713
omeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralKroger Company30142-394
equaline omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralUnited Natural Foods, Inc. dba UNFI41163-634
omeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralWalgreen Company0363-1819
berkley and jensen omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralBJWC68391-103
good neighbor pharmacy omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmerisource Bergen46122-616
good sense omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralL. Perrigo Company0113-0520
omeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralHyVee Inc42507-164
Leader OmeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralCardinal Health 110, LLC. dba Leader70000-0381
up and up omeprazoleomeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralTarget Corporation11673-212

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in