NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3475Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3475Add 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
50090-3475-05009034750030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3475-0)Marketed from Oct 9, 2019
50090-3475-15009034750190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3475-1)Marketed from Jun 14, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 tartrate4 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079141
Marketing start
Listing expires
Other FDA classes
Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 50090-3475_9031ca7e-ead2-404d-a98e-d8dbd2eff0d5SPL ID 9031ca7e-ead2-404d-a98e-d8dbd2eff0d5SPL set ID fd6c8b3d-a52a-4418-aa9c-0297db6c0807RxCUI 855189UNII 5T619TQR3R
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

N450090347500 followed by a unit qualifier and the quantity

Package 50090-3475-00. 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)

Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [ see CLINICAL STUDIES ( 14 ) ]. Tolterodine tartrate extended-release capsules are an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079141

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

FDA NDC Directory listings under ANDA 079141
ProductStrengthForm · routeLabelerProduct NDC
Tolterodine TartrateTolterodine tartrate 2 mg/1Capsule, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-7163
Tolterodine TartrateTolterodine tartrate 4 mg/1Capsule, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-7164

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