Over-the-counter drug · ANDA

equate lansoprazole delayed release (Lansoprazole) NDC 49035-411

Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-411Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0411Add 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
49035-411-0149035041101490350411011 BOTTLE in 1 CARTON (49035-411-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from May 5, 2014
49035-411-0349035041103490350411033 BOTTLE in 1 CARTON (49035-411-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from May 7, 2014

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)
equate lansoprazole delayed release
Generic name (nonproprietary)
lansoprazole
Active ingredients
Lansoprazole — 15 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Wal-Mart Stores IncNDC labeler code 49035
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 49035-411_c77bb311-5eed-4a6b-8f0f-09371f123e92SPL ID c77bb311-5eed-4a6b-8f0f-09371f123e92SPL set ID 3eb7a657-625a-46bf-a196-4ba6aa41a7bfRxCUI 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

N449035041101 followed by a unit qualifier and the quantity

Package 49035-0411-01. 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 49035-411

What is NDC 49035-411?
49035-411 is the product NDC for equate lansoprazole delayed release, Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by Wal-Mart Stores Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
equate lansoprazole delayed release (Lansoprazole).
What is the active ingredient?
Lansoprazole.
Who is the labeler?
Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for equate lansoprazole delayed release?
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 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
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
Prevacid 24 HRlansoprazoleLansoprazole 15 mg/1Capsule, Delayed releaseOralL. Perrigo Company0113-6117

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