Over-the-counter drug · ANDA

omeprazole (Omeprazole magnesium) NDC 51316-271

Omeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-271Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0271Add 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
51316-271-0351316027103513160271033 BOTTLE in 1 CARTON (51316-271-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51316-271-01)Marketed from Apr 1, 2025

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
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 51316-271_6fe0d098-2eb4-49b6-881f-fbe7e102bfcbSPL ID 6fe0d098-2eb4-49b6-881f-fbe7e102bfcbSPL set ID 8edfcc08-a14e-4579-bd44-045267de5b79RxCUI 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

N451316027103 followed by a unit qualifier and the quantity

Package 51316-0271-03. 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 51316-271

What is NDC 51316-271?
51316-271 is the product NDC for omeprazole (omeprazole magnesium), Omeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
omeprazole (Omeprazole magnesium).
What is the active ingredient?
Omeprazole magnesium.
Who is the labeler?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association, Inc.83324-30983324-0309-1483324-0309-42
OmeprazoleOmeprazole 20 mg/1Tablet, Orally disintegrating, Delayed releaseOralAmazon.com Services LLC72288-66672288-0666-5572288-0666-74
Omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-01573581-0015-03
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDiscount Drug Mart, Inc53943-03853943-0038-1453943-0038-42
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAmazon.com Services LLC72288-93472288-0934-01
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralH E B59640-69959640-0699-0159640-0699-03
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralUnit Dose Solutions, Inc.87441-06387441-0063-01
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway21130-78321130-0783-0121130-0783-03
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralPreferred Phharmaceuticals Inc.68788-410468788-4104-0168788-4104-0268788-4104-03+4 more
omeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-60672288-0606-03

All 253 omeprazole NDCs

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
omeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralMeijer, Inc.79481-3023
basic care omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-023
omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway21130-528
equate omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWALMART INC.79903-112
Omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-015
omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-6089
omeprazoleomeprazole magnesiumOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralMeijer, Inc.79481-0281
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway21130-783
Good Sense OmeprazoleomeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-6010
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-4099
OmeprazoleOmeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-843
OmeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralH E B59640-699
omeprazoleOmeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-606

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