Over-the-counter drug · ANDA
Berkley And Jensen Lansoprazole (Lansoprazole) NDC 68391-823
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-823-03 | 6839108230368391082303 | 3 BOTTLE in 1 PACKAGE (68391-823-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68391-823-00)Marketed from Oct 21, 2022 |
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)
- Berkley And Jensen Lansoprazole
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 15 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- 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 68391-823_0ad7d69d-29af-43c5-81a6-6f370591ef9fSPL ID 0ad7d69d-29af-43c5-81a6-6f370591ef9fSPL set ID b859e8dc-e42e-448d-89fa-2fc79d9cac32RxCUI 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
N468391082303followed by a unit qualifier and the quantityPackage 68391-0823-03. 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 68391-823
- What is NDC 68391-823?
- 68391-823 is the product NDC for Berkley And Jensen Lansoprazole (lansoprazole), Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Berkley And Jensen Lansoprazole (Lansoprazole).
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Berkley And Jensen 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 |
| 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 |
| Kirkland Signature Lansoprazolelansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Costco Wholesale Company | 63981-582 |
| 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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