Tolterodine tartrate NDC 33342-097

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-097Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0097Add 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 NDC	11-digit (billing)	Package
33342-097-09	33342009709	60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09)Marketed from Oct 8, 2020
33342-097-12	33342009712	10 BLISTER PACK in 1 CARTON (33342-097-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 8, 2020
33342-097-15	33342009715	500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15)Marketed from Oct 8, 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): Tolterodine tartrate
Generic name (nonproprietary): tolterodine tartrate
Active ingredients: Tolterodine tartrate — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203409
Marketing start: Oct 8, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 33342-097_fa641ff6-005b-47c5-bade-8709129d7ac9SPL ID fa641ff6-005b-47c5-bade-8709129d7ac9SPL set ID 3f2291c3-7e3c-41be-afa6-ef73ce896e30RxCUI 855178, 855194UNII 5T619TQR3RUPC 0333342097095
Pharmacologic class: Cholinergic Muscarinic 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

N433342009709 followed by a unit qualifier and the quantity

Package 33342-0097-09. 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 Nov 19, 2022.

Indications (excerpt from the label)

INDICATIONS & USAGE Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203409

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203409
Product	Strength	Form · route	Labeler	Product NDC
Tolterodine tartrate	Tolterodine tartrate 2 mg/1	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-098