Over-the-counter drug · ANDA
Lansoprazole NDC 0363-0037
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Walgreens company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-0037-14 | 0036300371400363003714 | 1 BOTTLE in 1 CARTON (0363-0037-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jan 15, 2023 | |
| 0363-0037-28 | 0036300372800363003728 | 2 BOTTLE in 1 CARTON (0363-0037-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jan 15, 2023 | |
| 0363-0037-42 | 0036300374200363003742 | 3 BOTTLE in 1 CARTON (0363-0037-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jan 15, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Lansoprazole
- Generic name (nonproprietary)
- lansoprazole
- Active ingredients
- Lansoprazole — 15 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Walgreens companyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202194
- Marketing start
- Listing expires
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0363-0037_52c147e2-098f-9442-9996-6a9f7fe92081SPL ID 52c147e2-098f-9442-9996-6a9f7fe92081SPL set ID 277093d5-cd0f-36ad-63d4-824a62d2a16cRxCUI 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
N400363003714followed by a unit qualifier and the quantityPackage 00363-0037-14. 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 0363-0037
- What is NDC 0363-0037?
- 0363-0037 is the product NDC for Lansoprazole, Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by Walgreens company. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lansoprazole.
- What is the active ingredient?
- Lansoprazole.
- Who is the labeler?
- Walgreens company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lansoprazole?
- 94 other product NDCs are listed under this name. See all Lansoprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lansoprazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lansoprazole | Lansoprazole 30 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Cardinal Health 107, LLC | 55154-8340 | 55154-8340-00 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed release pelletsOral | Preferred Pharmaceuticals Inc. | 68788-4141 | 68788-4141-0368788-4141-0668788-4141-09 |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-672 | 72288-0672-55 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-827 | 72288-0827-03 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed release pelletsOral | Safecor Health LLC | 48433-051 | 48433-0051-08 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Medcore LLC | 82461-713 | 82461-0713-30 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-310 | 33342-0310-07 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-311 | 33342-0311-07 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8621 | 68788-8621-0168788-8621-0368788-8621-06+2 more |
| Lansoprazole | Lansoprazole 15 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Aurobindo Pharma Limited | 65862-895 | 65862-0895-78 |
Other NDCs under ANDA 202194
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 |
|---|---|---|---|---|
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Rugby Laboratories, Inc | 0536-1368 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc. | 43598-109 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Inc. | 43598-161 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | AMERISOURCEBERGEN DRUG CORPORATION | 46122-744 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-739 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | LEADER/ Cardinal Health 110, Inc. | 70000-0612 |
| Lansoprazole | Lansoprazole 15 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association | 83324-001 |