Prescription drug · NDA
Ubrelvy (Ubrogepant) NDC 0023-6501
Ubrogepant 100 mg/1 · Tablet · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-6501-01 | 0002365010100023650101 | 1 PACKET in 1 BOX (0023-6501-01) / 1 TABLET in 1 PACKETMarketed from Dec 23, 2019 · Sample package | |
| 0023-6501-10 | 0002365011000023650110 | 10 PACKET in 1 BOX (0023-6501-10) / 1 TABLET in 1 PACKET (0023-6501-02)Marketed from Dec 23, 2019 | |
| 0023-6501-16 | 0002365011600023650116 | 16 PACKET in 1 BOX (0023-6501-16) / 1 TABLET in 1 PACKET (0023-6501-02)Marketed from Dec 23, 2019 | |
| 0023-6501-30 | 0002365013000023650130 | 30 PACKET in 1 BOX (0023-6501-30) / 1 TABLET in 1 PACKET (0023-6501-02)Marketed from Dec 23, 2019 |
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)
- Ubrelvy
- Generic name (nonproprietary)
- ubrogepant
- Active ingredients
- Ubrogepant — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211765
- Marketing start
- Listing expires
- Other FDA classes
- Calcitonin Gene-related Peptide Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0023-6501_a4b2fc64-0045-4595-8194-98b7f2734d5eSPL ID a4b2fc64-0045-4595-8194-98b7f2734d5eSPL set ID fd9f9458-fd96-4688-be3f-f77b3d1af6abRxCUI 2268221, 2268227, 2268229, 2268231UNII AD0O8X2QJR
- Pharmacologic class
- Calcitonin Gene-related Peptide Receptor Antagonist
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
N400023650101followed by a unit qualifier and the quantityPackage 00023-6501-01. 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)
UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0023-6501
- What is NDC 0023-6501?
- 0023-6501 is the product NDC for Ubrelvy (ubrogepant), Ubrogepant 100 mg/1 tablet, listed with the FDA by Allergan, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ubrelvy (Ubrogepant).
- What is the active ingredient?
- Ubrogepant.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ubrelvy?
- 3 other product NDCs are listed under this name. See all Ubrelvy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ubrelvy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ubrelvyubrogepant | Ubrogepant 50 mg/1 | TabletOral | Allergan, Inc. | 0023-6498 | 00023-6498-0100023-6498-0400023-6498-10+2 more |
| Ubrelvyubrogepant | Ubrogepant 50 mg/1 | TabletOral | Sportpharm LLC | 85766-280 | 85766-0280-0185766-0280-1085766-0280-16+1 more |
| Ubrelvyubrogepant | Ubrogepant 100 mg/1 | TabletOral | Sportpharm LLC | 85766-281 | 85766-0281-0185766-0281-1085766-0281-16+1 more |
Other NDCs under NDA 211765
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 |
|---|---|---|---|---|
| Ubrelvyubrogepant | Ubrogepant 50 mg/1 | TabletOral | Allergan, Inc. | 0023-6498 |
| Ubrelvyubrogepant | Ubrogepant 50 mg/1 | TabletOral | Sportpharm LLC | 85766-280 |
| Ubrelvyubrogepant | Ubrogepant 100 mg/1 | TabletOral | Sportpharm LLC | 85766-281 |