Prescription drug · ANDA
Dexlansoprazole NDC 0378-2086
Dexlansoprazole sesquihydrate 60 mg/1 · Capsule, Delayed release pellets · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-2086-77 | 0037820867700378208677 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2086-77)Marketed from Jan 22, 2024 | |
| 0378-2086-93 | 0037820869300378208693 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2086-93)Marketed from Jan 22, 2024 |
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)
- Dexlansoprazole
- Generic name (nonproprietary)
- dexlansoprazole
- Active ingredients
- Dexlansoprazole sesquihydrate — 60 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205205
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-2086_bd08545b-3f1d-44c5-bdd9-05acd7f69a0aSPL ID bd08545b-3f1d-44c5-bdd9-05acd7f69a0aSPL set ID 3f9699b5-7614-41cb-bd1d-ff02930e98f3RxCUI 833204, 833213UNII HS2S9VK3NHUPC 0303782086935, 0303782085938
- 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
N400378208677followed by a unit qualifier and the quantityPackage 00378-2086-77. 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 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 ol…
Excerpt only. Read the full label for complete information.
About NDC 0378-2086
- What is NDC 0378-2086?
- 0378-2086 is the product NDC for Dexlansoprazole, Dexlansoprazole sesquihydrate 60 mg/1 capsule, delayed release pellets, listed with the FDA by Mylan Pharmaceuticals Inc.. 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 sesquihydrate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 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 | Par Health USA, LLC | 49884-148 | 49884-0148-0949884-0148-11 |
| 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 205205
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 sesquihydrate 30 mg/1 | Capsule, Delayed release pelletsOral | Mylan Pharmaceuticals Inc. | 0378-2085 |