Prescription drug · NDA
Gemtesa (Vibegron) NDC 73336-075
Vibegron 75 mg/1 · Tablet, Film coated · Oral · Sumitomo Pharma America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73336-075-07 | 7333600750773336007507 | 1 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 29, 2020 | |
| 73336-075-30 | 7333600753073336007530 | 30 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)Marketed from Dec 29, 2020 | |
| 73336-075-90 | 7333600759073336007590 | 90 TABLET, FILM COATED in 1 BOTTLE (73336-075-90)Marketed from Dec 29, 2020 |
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)
- Gemtesa
- Generic name (nonproprietary)
- vibegron
- Active ingredients
- Vibegron — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sumitomo Pharma America, Inc.NDC labeler code 73336
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213006
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta3-Agonists (Mechanism)
- Identifiers
- Product ID 73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4SPL ID 6744a1cf-7abb-4623-85e3-8f67a9eb19d4SPL set ID 25f21d25-14f8-4fda-91f6-7aa8b68aa1c8RxCUI 2472315, 2472321UNII M5TSE03W5U
- Pharmacologic class
- beta3-Adrenergic Agonist
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
N473336007507followed by a unit qualifier and the quantityPackage 73336-0075-07. 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)
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). ( 1.2 ) 1.1 Overactive Bladder in Adults GEMTESA ® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. 1.2 Overactive Bladder in Adult Males with Benign Prostatic Hyperplasia (BPH) GEMTESA is indicated for the treatment of overactive b…
Excerpt only. Read the full label for complete information.
About NDC 73336-075
- What is NDC 73336-075?
- 73336-075 is the product NDC for Gemtesa (vibegron), Vibegron 75 mg/1 tablet, film coated, listed with the FDA by Sumitomo Pharma America, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gemtesa (Vibegron).
- What is the active ingredient?
- Vibegron.
- Who is the labeler?
- Sumitomo Pharma America, Inc., NDC labeler code 73336. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gemtesa?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.