Over-the-counter drug · ANDA

Good Sense Esomeprazole Magnesium (Esomeprazole) NDC 0113-0898

Esomeprazole 20 mg/1 · Capsule, Delayed release · Oral · L. Perrigo Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0113-0898Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00113-0898Add 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
0113-0898-0100113089801001130898011 BOTTLE in 1 CARTON (0113-0898-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2017
0113-0898-0200113089802001130898022 BOTTLE in 1 CARTON (0113-0898-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2017
0113-0898-0300113089803001130898033 BOTTLE in 1 CARTON (0113-0898-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 22, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Good Sense Esomeprazole Magnesium
Generic name (nonproprietary)
esomeprazole
Active ingredients
Esomeprazole — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
L. Perrigo CompanyNDC labeler code 0113
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 0113-0898_34b0e9f8-27ec-49a8-a373-2a43ce42861dSPL ID 34b0e9f8-27ec-49a8-a373-2a43ce42861dSPL set ID 4a89b4b5-5c42-44ee-98a9-e26a237aaef7RxCUI 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

N400113089801 followed by a unit qualifier and the quantity

Package 00113-0898-01. 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 0113-0898

What is NDC 0113-0898?
0113-0898 is the product NDC for Good Sense Esomeprazole Magnesium, Esomeprazole 20 mg/1 capsule, delayed release, listed with the FDA by L. Perrigo Company. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Good Sense Esomeprazole Magnesium (Esomeprazole).
What is the active ingredient?
Esomeprazole.
Who is the labeler?
L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Sense Esomeprazole Magnesium?
2 other product NDCs are listed under this name. See all Good Sense 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 Good Sense Esomeprazole Magnesium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
good sense esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-202200113-2022-02
good sense esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-065100113-0651-03

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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