Prescription drug · ANDA
Dexlansoprazole delayed release (dexlansoprazole) NDC 50090-6514
Dexlansoprazole 60 mg/1 · Capsule, Delayed release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6514-0 | 50090651400 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-0)Marketed from Jun 1, 2023 | |
| 50090-6514-1 | 50090651401 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-1)Marketed from Jun 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Dexlansoprazole delayed releaseSuffix: delayed release
- Generic name (nonproprietary)
- dexlansoprazole
- Active ingredients
- Dexlansoprazole — 60 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202666
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-6514_f84a485f-17d9-4fae-90aa-8a4b72fe7d1dSPL ID f84a485f-17d9-4fae-90aa-8a4b72fe7d1dSPL set ID 4f44e84f-6219-4445-a67d-df37d18b014dRxCUI 833213UNII UYE4T5I70X
- 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
N450090651400followed by a unit qualifier and the quantityPackage 50090-6514-00. 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)
Dexlansoprazole delayed-release capsules are proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 ) 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to m…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202666
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 |
|---|---|---|---|---|
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 24979-001 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-030 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 24979-002 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2239 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-746 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-747 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-3071 |