Over-the-counter drug · ANDA

omeprazole (omeprazole magnesium) NDC 21130-528

Omeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Safeway

NDC codes

FDA NDC Directory
Product NDC (as listed)21130-528Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21130-0528Add 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
21130-528-01211300528011 BOTTLE in 1 CARTON (21130-528-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jun 3, 2024
21130-528-03211300528033 BOTTLE in 1 CARTON (21130-528-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jun 3, 2024

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 magnesium
Active ingredients
Omeprazole magnesium — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Safeway
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216096
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 21130-528_e018508f-372e-4b81-9979-15dbd798b271SPL ID e018508f-372e-4b81-9979-15dbd798b271SPL set ID 7ae4d70f-08f1-4586-965f-5a32fbe21591RxCUI 198051UNII 426QFE7XLK
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

N421130052801 followed by a unit qualifier and the quantity

Package 21130-0528-01. 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 ANDA 216096

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

FDA NDC Directory listings under ANDA 216096
ProductStrengthForm · routeLabelerProduct NDC
Good Sense OmeprazoleomeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-6010
omeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-606
omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-271
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-843
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralH E B59640-699
omeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralMeijer, Inc.79481-3023
omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-6089
equate omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWALMART INC.79903-112
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway21130-783
basic care omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-023
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-4099
Omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-015
omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralMeijer, Inc.79481-0281

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