Over-the-counter drug · ANDA
Kirkland Signature Lansoprazole (Lansoprazole) NDC 63981-582
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Costco Wholesale Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63981-582-03 | 6398105820363981058203 | 3 BOTTLE in 1 PACKAGE (63981-582-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63981-582-01)Marketed from Nov 22, 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)
- Kirkland Signature Lansoprazole
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 15 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Costco Wholesale CompanyNDC labeler code 63981
- 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 63981-582_a0e3bf06-669d-4ed3-8eae-a155693dc439SPL ID a0e3bf06-669d-4ed3-8eae-a155693dc439SPL set ID 326aabe6-c4ac-4bca-949f-38015dcbaf4eRxCUI 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
N463981058203followed by a unit qualifier and the quantityPackage 63981-0582-03. 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.
About NDC 63981-582
- What is NDC 63981-582?
- 63981-582 is the product NDC for Kirkland Signature Lansoprazole (lansoprazole), Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by Costco Wholesale Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kirkland Signature Lansoprazole (Lansoprazole).
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- Costco Wholesale Company, NDC labeler code 63981. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kirkland Signature Lansoprazole?
- 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| basic care lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-301 |
| basic care lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-343 |
| Berkley And Jensen Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | BJWC | 68391-823 |
| careone acid reducerlansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Retail Business Services, LLC | 72476-020 |
| dg health lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dolgencorp Inc | 55910-307 |
| equaline lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-150 |
| equate lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | WALMART INC. | 79903-068 |
| equate lansoprazole delayed releaselansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Wal-Mart Stores Inc | 49035-411 |
| foster and thrive acid reducerlansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1103 |
| good neighbor pharmacy lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Amerisource Bergen | 46122-698 |
| Good Sense Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | L. Perrigo Company | 0113-1114 |
| lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Walgreen Company | 0363-1212 |
| lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Meijer Distribution Inc | 41250-391 |
| lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Padagis Israel Pharmaceuticals Ltd | 45802-878 |
| lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Publix Super Markets Inc | 56062-117 |
| lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Publix Super Markets Inc | 56062-283 |
| lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-9695 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-827 |
| Members Mark Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Sam's West Inc | 68196-279 |
| Prevacid 24 HRlansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | L. Perrigo Company | 0113-6117 |
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