Over-the-counter drug · ANDA

topcare esomeprazole magnesium (esomeprazole magnesium) NDC 36800-627

Esomeprazole magnesium dihydrate 20 mg/1 · Capsule, Delayed release · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-627Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0627Add 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
36800-627-01368000627011 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 12, 2020
36800-627-03368000627033 BOTTLE in 1 CARTON (36800-627-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 12, 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)
topcare 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 207193
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 36800-627_61351d9f-87dd-4586-a46a-9ab7fabe41ceSPL ID 61351d9f-87dd-4586-a46a-9ab7fabe41ceSPL set ID 86384845-0bea-490b-b04a-5770ef88b639RxCUI 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

N436800062701 followed by a unit qualifier and the quantity

Package 36800-0627-01. 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)

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
Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-220
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralRite Aid Corporation11822-0024
Esomeprazole Magnesium Minisesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-174
Up and Up Esomeprazole Magnesiumesomeprazole magnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralTarget Corporation11673-753
Esomeprazole Magnesiumesomeprazole magnesium dihydrateEsomeprazole 20 mg/1Capsule, Delayed releaseOralWalgreen Company0363-1699
esomeprazole magnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralMeijer Distribution Inc41250-727
equate esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralWALMART INC.79903-293
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-669
basic care esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-700
careone esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmerican Sales Company41520-727
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralHyVee Inc42507-774
good sense esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-0651
Exchange Select Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralArmy & Air Force Exchange Service55301-898
DG Health Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralDolgencorp Inc55910-593
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralHyVee Inc42507-898
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-780
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralCVS Pharmacy69842-898
Foster and Thrive Acid ReduceresomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralStrategic Sourcing Services LLC70677-1099
kirkland signature esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralCostco Wholesale Company63981-898
up and up esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralTarget Corporation11673-898

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