Over-the-counter drug · ANDA

topcare lansoprazole (Lansoprazole) NDC 36800-392

Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Topco Associates LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)36800-392Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36800-0392Add 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
36800-392-0136800039201368000392011 BOTTLE in 1 CARTON (36800-392-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 29, 2021
36800-392-0336800039203368000392033 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 29, 2021

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 lansoprazole
Generic name (nonproprietary)
lansoprazole
Active ingredients
Lansoprazole — 15 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 202319
Marketing start
Listing expires
Other FDA classes
Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282fSPL ID f5217e63-e0c1-4899-8bf0-e480d65e282fSPL set ID 73aec019-5337-48a4-b95c-993fff9cfc2aRxCUI 596843UNII 0K5C5T2QPG
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

N436800039201 followed by a unit qualifier and the quantity

Package 36800-0392-01. 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)

Use • 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 36800-392

What is NDC 36800-392?
36800-392 is the product NDC for topcare lansoprazole (lansoprazole), Lansoprazole 15 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 lansoprazole (Lansoprazole).
What is the active ingredient?
Lansoprazole.
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 lansoprazole?
1 other product NDC are listed under this name. See all topcare lansoprazole 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 topcare lansoprazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
topcare LansoprazolelansoprazoleLansoprazole 15 mg/1Tablet, Orally disintegrating, Delayed releaseOralTopco Associates LLC36800-29536800-0295-74

Other NDCs under ANDA 202319

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

FDA NDC Directory listings under ANDA 202319
ProductStrengthForm · routeLabelerProduct NDC
basic care lansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-301
basic care lansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-343
Berkley And Jensen LansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralBJWC68391-823
careone acid reducerlansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralRetail Business Services, LLC72476-020
dg health lansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralDolgencorp Inc55910-307
equaline lansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralUnited Natural Foods, Inc. dba UNFI41163-150
equate lansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralWALMART INC.79903-068
equate lansoprazole delayed releaselansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralWal-Mart Stores Inc49035-411
foster and thrive acid reducerlansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralStrategic Sourcing Services LLC70677-1103
good neighbor pharmacy lansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAmerisource Bergen46122-698
Good Sense LansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-1114
Kirkland Signature LansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralCostco Wholesale Company63981-582
lansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralWalgreen Company0363-1212
lansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralMeijer Distribution Inc41250-391
lansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralPadagis Israel Pharmaceuticals Ltd45802-878
lansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralPublix Super Markets Inc56062-117
lansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralPublix Super Markets Inc56062-283
lansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-9695
LansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-827
Members Mark LansoprazolelansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralSam's West Inc68196-279

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