Over-the-counter drug · ANDA

Esomeprazole Magnesium NDC 57483-225

Esomeprazole magnesium dihydrate 20 mg/1 · Capsule, Delayed release · Oral · INNOVUS PHARMACEUTICALS, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)57483-225Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57483-0225Add 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
57483-225-42574830225423 BOTTLE in 1 CARTON (57483-225-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from May 25, 2023

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 magnesium
Active ingredients
Esomeprazole magnesium dihydrate — 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 209339
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 57483-225_3d8224e0-9922-4d9b-89c0-280504788f3cSPL ID 3d8224e0-9922-4d9b-89c0-280504788f3cSPL set ID a32039b7-8475-4ec5-abaf-07f9aee3954bRxCUI 606726UNII 36H71644EQ
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

N457483022542 followed by a unit qualifier and the quantity

Package 57483-0225-42. 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)

Other NDCs under ANDA 209339

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

FDA NDC Directory listings under ANDA 209339
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAmerisource Bergen46122-736
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralBest Choice63941-971
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAhold U.S.A., Inc,60000-109
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralRetail Business Services, LLC.72476-500
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralPublix56062-020
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 20 mg/1Capsule, Delayed releaseOralAmerisource Bergen46122-821
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralWALGREEN CO.0363-0508
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAurohealth LLC58602-707
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralFamily Dollar Stores, LLC55319-051
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralBetter Living Brands LLC21130-100
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1CapsuleOralYYBA CORP73581-014
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAurohealth LLC58602-809
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAurohealth LLC58602-822
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAurohealth LLC58602-846
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralLEADER/ CARDINAL HEALTH 110, INC.70000-0731
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralWal-Mart Stores, Inc.49035-980
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 20 mg/1Capsule, Delayed releaseOralLEADER/ CARDINAL HEALTH 110, INC.70000-0738
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 20 mg/1Capsule, Delayed releaseOralAurohealth LLC58602-896
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralCVS Pharmacy, Inc.69842-248

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