NDC codes

FDA NDC Directory
Product NDC (as listed)73336-075Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73336-0075Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
73336-075-0773336007507733360075071 BOTTLE in 1 CARTON (73336-075-07) / 7 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 29, 2020
73336-075-30733360075307333600753030 TABLET, FILM COATED in 1 BOTTLE (73336-075-30)Marketed from Dec 29, 2020
73336-075-90733360075907333600759090 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

N473336007507 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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