Prescription drug · ANDA
Lansoprazole NDC 0093-7350
Lansoprazole 15 mg/1 · Capsule, Delayed release · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7350-56 | 00093735056 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-7350-56)Marketed from Nov 11, 2009 |
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
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077255
- Marketing start
- Marketing end
- Other FDA classes
- Inhibition Gastric Acid Secretion (Physiologic effect)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-7350_03e97384-9aeb-4bf5-81ba-8d8a65eae03cSPL ID 03e97384-9aeb-4bf5-81ba-8d8a65eae03cSPL set ID 427cf924-be17-47dc-8f77-115fa2f3fe17RxCUI 311277, 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
N400093735056followed by a unit qualifier and the quantityPackage 00093-7350-56. 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)
Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults. ( 1.1 ) • Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. ( 1.2 ) • Maintenance of healed duodenal ulcers in adults. ( 1.3 ) • Treatment of active benign gastric ulcer in adults. ( 1.4 ) • Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5 ) • Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7 ) • Treatment of erosive esophagitis…
Excerpt only. Read the full label for complete information.
About NDC 0093-7350
- What is NDC 0093-7350?
- 0093-7350 is the product NDC for Lansoprazole, Lansoprazole 15 mg/1 capsule, delayed release, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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 077255
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 30 mg/1 | Capsule, Delayed releaseOral | Teva Pharmaceuticals USA, Inc. | 0093-7351 |
| Lansoprazole | Lansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-152 |