Over-the-counter drug · ANDA

esomeprazole magnesium (Esomeprazole) NDC 41250-900

Esomeprazole 20 mg/1 · Capsule, Delayed release · Oral · Meijer Distribution Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)41250-900Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0900Add 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
41250-900-01412500900011 BOTTLE in 1 CARTON (41250-900-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2017
41250-900-02412500900022 BOTTLE in 1 CARTON (41250-900-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2017
41250-900-03412500900033 BOTTLE in 1 CARTON (41250-900-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2017

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
Labeler
Meijer Distribution IncNDC labeler code 41250
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 41250-900_bda89e2d-5798-402f-9ddb-c8f4d7fc9140SPL ID bda89e2d-5798-402f-9ddb-c8f4d7fc9140SPL set ID 126c269b-260d-40f4-879d-169c09251c67RxCUI 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

N441250090001 followed by a unit qualifier and the quantity

Package 41250-0900-01. 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 41250-900

What is NDC 41250-900?
41250-900 is the product NDC for esomeprazole magnesium (esomeprazole), Esomeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Meijer Distribution Inc. It has 3 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?
Meijer Distribution Inc, NDC labeler code 41250. 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?
174 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 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
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralAvPAK50268-27250268-0272-13
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-458170518-4581-00

All 175 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
Up and Up Esomeprazole Magnesiumesomeprazole magnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralTarget Corporation11673-753
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralHyVee Inc42507-774
Exchange Select Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralArmy & Air Force Exchange Service55301-898
careone esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmerican Sales Company41520-727
DG Health Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralDolgencorp Inc55910-593
kirkland signature esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralCostco Wholesale Company63981-898
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-7223
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-780
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralHyVee Inc42507-898
dg health esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralDolgencorp Inc55910-640
topcare esomeprazole magnesiumesomeprazole magnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralTopco Associates LLC36800-627
good sense esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-2022
signature care esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralSafeway21130-714
basic care esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-898
signature care esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralSafeway21130-088
up and up esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralTarget Corporation11673-898
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralKroger Company30142-273
leader esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralCardinal Health 110, LLC. dba Leader70000-0727
Esomeprazole Magnesiumesomeprazole magnesium dihydrateEsomeprazole 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-1699
Good Sense Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-0898

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