Tolterodine Tartrate NDC 16571-127

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-127Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0127Add 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
16571-127-01	16571012701	100 TABLET, FILM COATED in 1 BOTTLE (16571-127-01)Marketed from Jan 24, 2020
16571-127-06	16571012706	60 TABLET, FILM COATED in 1 BOTTLE (16571-127-06)Marketed from Jan 24, 2020
16571-127-50	16571012750	500 TABLET, FILM COATED in 1 BOTTLE (16571-127-50)Marketed from Jan 24, 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 — 2 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204721
Marketing start: Jan 24, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 16571-127_d56e7ced-4633-4325-8e3d-166c84c05886SPL ID d56e7ced-4633-4325-8e3d-166c84c05886SPL set ID b9ba8ad2-27f6-4f18-bd84-73659047910eRxCUI 855178, 855194UNII 5T619TQR3RUPC 0316571126064, 0316571127061
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

N416571012701 followed by a unit qualifier and the quantity

Package 16571-0127-01. 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 Apr 1, 2025.

Indications (excerpt from the label)

INDICATIONS AND 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 204721

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

FDA NDC Directory listings under ANDA 204721
Product	Strength	Form · route	Labeler	Product NDC
Tolterodine Tartrate	Tolterodine tartrate 1 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-126