Over-the-counter drug · ANDA

Esomeprazole Magnesium (Esomeprazole) NDC 51316-220

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

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-220Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0220Add 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
51316-220-0151316022001513160220011 BOTTLE in 1 CARTON (51316-220-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 13, 2024
51316-220-0351316022003513160220033 BOTTLE in 1 CARTON (51316-220-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 13, 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)
Esomeprazole Magnesium
Generic name (nonproprietary)
esomeprazole
Active ingredients
Esomeprazole — 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 207193
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 51316-220_ff0d65ca-7ca9-4689-b5f9-1065402c91b2SPL ID ff0d65ca-7ca9-4689-b5f9-1065402c91b2SPL set ID 19fa87e4-8225-4969-9857-1bf43db4427bRxCUI 606726UNII N3PA6559FT
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

N451316022001 followed by a unit qualifier and the quantity

Package 51316-0220-01. 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)

Uses • 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 51316-220

What is NDC 51316-220?
51316-220 is the product NDC for Esomeprazole Magnesium (esomeprazole), Esomeprazole 20 mg/1 capsule, delayed release, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esomeprazole Magnesium (Esomeprazole).
What is the active ingredient?
Esomeprazole.
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 Esomeprazole Magnesium?
179 other product NDCs are listed under this name. See all Esomeprazole Magnesium 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 Esomeprazole Magnesium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-477670518-4776-00
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association, Inc.83324-32883324-0328-1483324-0328-42
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-87760760-0877-60
Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-56372288-0563-01
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-78072288-0780-03
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-93460687-0934-21
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-66972288-0669-0172288-0669-03
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralH-E-B37808-64637808-0646-4137808-0646-4537808-0646-82
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.64980-66464980-0664-1964980-0664-41
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1CapsuleOralYYBA CORP73581-01473581-0014-42

All 180 Esomeprazole Magnesium NDCs

Other NDCs under ANDA 207193

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

FDA NDC Directory listings under ANDA 207193
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-560
basic care esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-700
basic care esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-898
berkley and jensen heartburn treatmentesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralBJWC68391-898
careone esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmerican Sales Company41520-727
dg health esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralDolgencorp, LLC55910-250
DG Health Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralDolgencorp Inc55910-593
dg health esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralDolgencorp Inc55910-640
equate esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralWal-Mart Stores Inc49035-921
equate esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralWALMART INC.79903-293
Equate Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralWALMART INC.79903-419
Esomeprazole Magnesiumesomeprazole magnesium dihydrateEsomeprazole 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-1699
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-7223
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralRite Aid Corporation11822-0024
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralRite Aid Corporation11822-0898
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralKroger Company30142-273
Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralH E B37808-719
esomeprazole magnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralMeijer Distribution Inc41250-727
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralMeijer Distribution Inc41250-900
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralHyVee Inc42507-774

Showing 20 of 39.

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