What is NDC 51316-061?

51316-061 is the product NDC for Omeprazole, Omeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by CVS Pharamacy, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

CVS Pharamacy, Inc, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Omeprazole?

252 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Omeprazole NDC 51316-061 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51316-061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51316-0061Add 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 NDC	11-digit (billing)	Package	Copy
51316-061-28	5131600612851316006128	2 BOTTLE in 1 CARTON (51316-061-28) / 28 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jan 9, 2021

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
Active ingredients: Omeprazole magnesium — 20 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: CVS Pharamacy, IncNDC labeler code 51316
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210593
Marketing start: Jan 9, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 51316-061_a3b8b93d-6725-4c5c-8b80-dcc27e408501SPL ID a3b8b93d-6725-4c5c-8b80-dcc27e408501SPL set ID 0769e47f-f8f1-4b1c-a8cc-7c8385c74070RxCUI 198051UNII 426QFE7XLKUPC 0050428320761
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

N451316006128 followed by a unit qualifier and the quantity

Package 51316-0061-28. 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 Apr 16, 2021.

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 51316-061

What is NDC 51316-061?: 51316-061 is the product NDC for Omeprazole, Omeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by CVS Pharamacy, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Omeprazole.
What is the active ingredient?: Omeprazole magnesium.
Who is the labeler?: CVS Pharamacy, Inc, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Omeprazole?: 252 other product NDCs are listed under this name. See all 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 Omeprazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Chain Drug Marketing Association, Inc.	83324-309	83324-0309-1483324-0309-42
Omeprazole	Omeprazole 20 mg/1	Tablet, Orally disintegrating, Delayed releaseOral	Amazon.com Services LLC	72288-666	72288-0666-5572288-0666-74
Omeprazoleomeprazole magnesium	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	YYBA CORP	73581-015	73581-0015-03
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Discount Drug Mart, Inc	53943-038	53943-0038-1453943-0038-42
Omeprazole	Omeprazole 20 mg/1	Tablet, Delayed releaseOral	Amazon.com Services LLC	72288-934	72288-0934-01
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	H E B	59640-699	59640-0699-0159640-0699-03
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Unit Dose Solutions, Inc.	87441-063	87441-0063-01
Omeprazole	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Safeway	21130-783	21130-0783-0121130-0783-03
Omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Preferred Phharmaceuticals Inc.	68788-4104	68788-4104-0168788-4104-0268788-4104-03+4 more
omeprazole	Omeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-606	72288-0606-03

All 253 Omeprazole NDCs

Other NDCs under ANDA 210593

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

FDA NDC Directory listings under ANDA 210593
Product	Strength	Form · route	Labeler	Product NDC
Omeprazoleomeprazole magnesium	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Walgreen Company	0363-9980
Omeprazoleomeprazole magnesium	Omeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	UP & UP	11673-948
omeprazole	Omeprazole magnesium 20.6 mg/1	Capsule, Delayed releaseOral	Rite Aid	11822-0061
omeprazole	Omeprazole magnesium 20.6 mg/1	Capsule, Delayed releaseOral	INNOVUS PHARMACEUTICALS, INC.	57483-740
Omeprazole	Omeprazole magnesium 20.6 mg/1	CapsuleOral	Meijer Distribution Inc.	79481-0061