What is NDC 36800-627?

36800-627 is the product NDC for topcare esomeprazole magnesium (esomeprazole magnesium), Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

topcare esomeprazole magnesium (Esomeprazole magnesium).

What is the active ingredient?

Esomeprazole magnesium dihydrate.

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for topcare esomeprazole magnesium?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

topcare esomeprazole magnesium NDC 36800-627

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 NDC	11-digit (billing)	Package	Copy
36800-627-01	3680006270136800062701	1 BOTTLE in 1 CARTON (36800-627-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 12, 2020
36800-627-03	3680006270336800062703	3 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
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207193
Marketing start: Mar 12, 2020
Listing expires: Dec 31, 2026
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 Sep 1, 2024.

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 36800-627

What is NDC 36800-627?: 36800-627 is the product NDC for topcare esomeprazole magnesium (esomeprazole magnesium), Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: topcare esomeprazole magnesium (Esomeprazole magnesium).
What is the active ingredient?: Esomeprazole magnesium dihydrate.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for topcare esomeprazole magnesium?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Product	Strength	Form · route	Labeler	Product NDC
Basic Care Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-560
basic care esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-700
basic care esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-898
berkley and jensen heartburn treatmentesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	BJWC	68391-898
careone esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	American Sales Company	41520-727
dg health esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Dolgencorp, LLC	55910-250
DG Health Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Dolgencorp Inc	55910-593
dg health esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Dolgencorp Inc	55910-640
equate esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Wal-Mart Stores Inc	49035-921
equate esomeprazole magnesiumesomeprazole magnesium dihydrate	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	WALMART INC.	79903-293
Equate Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	WALMART INC.	79903-419
Esomeprazole Magnesiumesomeprazole magnesium dihydrate	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Walgreen Company	0363-1699
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Walgreen Company	0363-7223
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Rite Aid Corporation	11822-0024
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Rite Aid Corporation	11822-0898
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Kroger Company	30142-273
Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	H E B	37808-719
esomeprazole magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Meijer Distribution Inc	41250-727
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Meijer Distribution Inc	41250-900
esomeprazole magnesiumesomeprazole magnesium dihydrate	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	HyVee Inc	42507-774

Showing 20 of 40.

topcare esomeprazole magnesium (Esomeprazole magnesium) NDC 36800-627