Over-the-counter drug · ANDA

Esomeprazole (Esomeprazole magnesium) NDC 57483-900

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

NDC codes

FDA NDC Directory
Product NDC (as listed)57483-900Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57483-0900Add 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
57483-900-4257483090042574830900423 BOTTLE in 1 CARTON (57483-900-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 2020

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
Generic name (nonproprietary)
esomeprazole magnesium
Active ingredients
Esomeprazole magnesium trihydrate — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
INNOVUS PHARMACEUTICALS, INC.NDC labeler code 57483
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212866
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592bSPL ID 8f25bf5e-bf0d-413e-8f91-d3537939592bSPL set ID b3d10f0b-52af-408c-9b3d-f8f25f7c42bdRxCUI 606726UNII R6DXU4WAY9
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

N457483090042 followed by a unit qualifier and the quantity

Package 57483-0900-42. 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)

About NDC 57483-900

What is NDC 57483-900?
57483-900 is the product NDC for Esomeprazole (esomeprazole magnesium), Esomeprazole magnesium trihydrate 20 mg/1 capsule, delayed release, listed with the FDA by INNOVUS PHARMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esomeprazole (Esomeprazole magnesium).
What is the active ingredient?
Esomeprazole magnesium trihydrate.
Who is the labeler?
INNOVUS PHARMACEUTICALS, INC., NDC labeler code 57483. 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?
10 other product NDCs are listed under this name. See all Esomeprazole 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralGERI-CARE PHARMACEUTICALS, CORP57896-74057896-0740-42
esomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-30633342-0306-0733342-0306-10
esomeprazoleEsomeprazole 40 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-30733342-0307-0733342-0307-10
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-01373581-0013-42
EsomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway, Inc.21130-92621130-0926-1421130-0926-2821130-0926-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCVS51316-71551316-0715-1451316-0715-2851316-0715-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1TabletOralHARRIS TEETER72036-98272036-0982-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralOhm Laboratories Inc.51660-02751660-0027-1451660-0027-2751660-0027-44
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralVALU MERCHANDISERS COMPANY63941-99963941-0999-1463941-0999-42
esomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralTHE KROGER COMPANY30142-98930142-0989-28

Other NDCs under ANDA 212866

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

FDA NDC Directory listings under ANDA 212866
ProductStrengthForm · routeLabelerProduct NDC
EsomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway, Inc.21130-926
esomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralTHE KROGER COMPANY30142-989
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCVS51316-715
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralOhm Laboratories Inc.51660-027
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralGERI-CARE PHARMACEUTICALS, CORP57896-740
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralVALU MERCHANDISERS COMPANY63941-999
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1TabletOralHARRIS TEETER72036-982
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-013
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralLITTLE PHARMA, INC.72559-011

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