Prescription drug · ANDA
Dexlansoprazole NDC 49884-148
Dexlansoprazole 60 mg/1 · Capsule, Delayed release · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-148-09 | 4988401480949884014809 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09)Marketed from Nov 22, 2022 | |
| 49884-148-11 | 4988401481149884014811 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11)Marketed from Nov 22, 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)
- Dexlansoprazole
- Generic name (nonproprietary)
- dexlansoprazole
- Active ingredients
- Dexlansoprazole — 60 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202294
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 49884-148_d173ea78-6398-49ea-8742-5d4093250cfdSPL ID d173ea78-6398-49ea-8742-5d4093250cfdSPL set ID d7452a26-db20-42fc-868a-a3e3606ca895RxCUI 833204, 833213UNII UYE4T5I70XUPC 0349884147112, 0349884148096
- 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
N449884014809followed by a unit qualifier and the quantityPackage 49884-0148-09. 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 is a 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 maintain healing of EE an…
Excerpt only. Read the full label for complete information.
About NDC 49884-148
- What is NDC 49884-148?
- 49884-148 is the product NDC for Dexlansoprazole, Dexlansoprazole 60 mg/1 capsule, delayed release, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexlansoprazole.
- What is the active ingredient?
- Dexlansoprazole.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. 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?
- 10 other product NDCs are listed under this name. See all Dexlansoprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexlansoprazole 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 | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-823 | 46708-0823-3046708-0823-90 |
| Dexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Limited | 46708-824 | 46708-0824-3046708-0824-90 |
| Dexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-823 | 62332-0823-3062332-0823-90 |
| Dexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Alembic Pharmaceuticals Inc. | 62332-824 | 62332-0824-3062332-0824-90 |
| Dexlansoprazole | Dexlansoprazole sesquihydrate 30 mg/1 | Capsule, Delayed release pelletsOral | Mylan Pharmaceuticals Inc. | 0378-2085 | 00378-2085-93 |
| Dexlansoprazole | Dexlansoprazole sesquihydrate 60 mg/1 | Capsule, Delayed release pelletsOral | Mylan Pharmaceuticals Inc. | 0378-2086 | 00378-2086-7700378-2086-93 |
| Dexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Par Health USA, LLC | 49884-147 | 49884-0147-11 |
| Dexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2244 | 72162-2244-03 |
| Dexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7451 | 50090-7451-0050090-7451-01 |
| Dexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2214 | 72162-2214-03 |
Other NDCs under ANDA 202294
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 | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Par Health USA, LLC | 49884-147 |
| Dexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7451 |
| Dexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2214 |
| Dexlansoprazole | Dexlansoprazole 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2244 |