Over-the-counter drug · ANDA

Acid Reducer (omeprazole) NDC 70000-0521

Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · Cardinal Health

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0521Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0521Add 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
70000-0521-1700000521011 BOTTLE in 1 CARTON (70000-0521-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jun 6, 2018
70000-0521-2700000521021 BLISTER PACK in 1 CARTON (70000-0521-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Oct 21, 2020
70000-0521-3700000521032 BOTTLE in 1 CARTON (70000-0521-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Oct 21, 2020
70000-0521-4700000521043 BOTTLE in 1 CARTON (70000-0521-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Oct 21, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Acid Reducer
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole magnesium — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206877
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 70000-0521_a54de89f-8710-4fc7-97c3-8607e5974263SPL ID a54de89f-8710-4fc7-97c3-8607e5974263SPL set ID 230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8RxCUI 402014UNII 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

N470000052101 followed by a unit qualifier and the quantity

Package 70000-0521-01. 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 206877

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

FDA NDC Directory listings under ANDA 206877
ProductStrengthForm · routeLabelerProduct NDC
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralNORTHEAST PHARMA80136-852
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralKROGER COMPANY30142-077
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralRugby Laboratories0536-1322
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralINNOVUS PHARMACEUTICALS, INC.57483-120
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralBest Choice63941-006
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralBi-Mart37835-189
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralDISCOUNT DRUG MART53943-016
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralWinco Foods, LLC.67091-316
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralFred's, Inc.55315-996
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralCVS Pharmacy, Inc.69842-941
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralFamily Dollar Stores, LLC55319-037
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralAurohealth LLC58602-729
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralRELIABLE 1 LABORATORIES LLC69618-054
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOral7-Eleven10202-722
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralAurohealth LLC58602-826
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralWALGREEN CO.0363-1008
Amazon Basic Care OmeprazoleomeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-409
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralAurohealth LLC58602-850
Acid ReduceromeprazoleOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralWal-Mart Stores, Inc.49035-983

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