Prescription drug · NDA
Dexilant (Dexlansoprazole) NDC 64764-171
Dexlansoprazole 30 mg/1 · Capsule, Delayed release · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-171-00 | 6476401710064764017100 | 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-00)Marketed from Apr 12, 2010 | |
| 64764-171-01 | 6476401710164764017101 | 5 BLISTER PACK in 1 TRAY (64764-171-01) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Apr 12, 2010 | |
| 64764-171-03 | 6476401710364764017103 | 1 BOTTLE in 1 CARTON (64764-171-03) / 5 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Apr 12, 2010 | |
| 64764-171-11 | 6476401711164764017111 | 10 BLISTER PACK in 1 CARTON (64764-171-11) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Apr 12, 2010 | |
| 64764-171-19 | 6476401711964764017119 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-19)Marketed from Apr 12, 2010 | |
| 64764-171-30 | 6476401713064764017130 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-30)Marketed from Apr 12, 2010 | |
| 64764-171-90 | 6476401719064764017190 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-90)Marketed from Apr 12, 2010 |
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)
- Dexilant
- Generic name (nonproprietary)
- dexlansoprazole
- Active ingredients
- Dexlansoprazole — 30 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 64764
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022287
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 64764-171_402fdd3a-6183-4a0d-85ac-61d4221fc921SPL ID 402fdd3a-6183-4a0d-85ac-61d4221fc921SPL set ID 9819f033-3bbe-442e-8e92-45fec77b237dRxCUI 833204, 833213, 902624, 902626UNII UYE4T5I70XUPC 0364764175306, 0364764171308
- 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
N464764017100followed by a unit qualifier and the quantityPackage 64764-0171-00. 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)
DEXILANT 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 DEXILANT ® is 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 DEXILANT is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in pa…
Excerpt only. Read the full label for complete information.
About NDC 64764-171
- What is NDC 64764-171?
- 64764-171 is the product NDC for Dexilant (dexlansoprazole), Dexlansoprazole 30 mg/1 capsule, delayed release, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexilant (Dexlansoprazole).
- What is the active ingredient?
- Dexlansoprazole.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 64764. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexilant?
- 1 other product NDC are listed under this name. See all Dexilant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexilant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexilantdexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | Takeda Pharmaceuticals America, Inc. | 64764-175 | 64764-0175-0064764-0175-0164764-0175-02+4 more |
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 60 mg/1 | Capsule, Delayed releaseOral | Takeda Pharmaceuticals America, Inc. | 64764-175 |
| Dexlansoprazole delayed releasedexlansoprazole | Dexlansoprazole 60 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5944 |