Prescription drug · NDA AUTHORIZED GENERIC
Dexlansoprazole delayed release (Dexlansoprazole) NDC 50090-5944
Dexlansoprazole 60 mg/1 · Capsule, Delayed release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5944-0 | 5009059440050090594400 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5944-0)Marketed from Mar 17, 2022 | |
| 50090-5944-1 | 5009059440150090594401 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5944-1)Marketed from Apr 1, 2022 |
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 SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022287
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5944_275745bb-b010-45d6-9541-78d365e2dd46SPL ID 275745bb-b010-45d6-9541-78d365e2dd46SPL set ID 7c7698da-3cda-4301-ae93-02fb64b9c90dRxCUI 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
N450090594400followed by a unit qualifier and the quantityPackage 50090-5944-00. 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.
About NDC 50090-5944
- What is NDC 50090-5944?
- 50090-5944 is the product NDC for Dexlansoprazole delayed release (dexlansoprazole), Dexlansoprazole 60 mg/1 capsule, delayed release, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexlansoprazole delayed release (Dexlansoprazole).
- What is the active ingredient?
- Dexlansoprazole.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexlansoprazole delayed release?
- 8 other product NDCs are listed under this name. See all Dexlansoprazole delayed release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexlansoprazole delayed release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 24979-001 | 24979-0001-0624979-0001-07 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Upsher-Smith Laboratories, LLC | 24979-002 | 24979-0002-0624979-0002-07 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6514 | 50090-6514-0050090-6514-01 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-3071 | 71335-3071-01 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2239 | 72162-2239-0372162-2239-09 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-746 | 51407-0746-30 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-747 | 51407-0747-3051407-0747-90 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-030 | 53401-0030-88 |
Other NDCs under NDA 022287
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 |
|---|---|---|---|---|
| Dexilantdexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Takeda Pharmaceuticals America, Inc. | 64764-171 |
| Dexilantdexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Takeda Pharmaceuticals America, Inc. | 64764-175 |