fesoterodine fumarate NDC 68382-480

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-480Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0480Add 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
68382-480-06	68382048006	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-06)Marketed from Dec 7, 2017
68382-480-16	68382048016	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-16)Marketed from Dec 7, 2017
68382-480-77	68382048077	10 BLISTER PACK in 1 CARTON (68382-480-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-480-30)Marketed from Dec 7, 2017

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): fesoterodine fumarate
Generic name (nonproprietary): fesoterodine fumarate
Active ingredients: Fesoterodine fumarate — 8 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204946
Marketing start: Dec 7, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 68382-480_3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5SPL ID 3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5SPL set ID 8c68e918-b47b-466d-80bc-4f521aa74607RxCUI 810071, 810077UNII EOS72165S7UPC 0368382479068, 0368382480064

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

N468382048006 followed by a unit qualifier and the quantity

Package 68382-0480-06. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 204946

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

FDA NDC Directory listings under ANDA 204946
Product	Strength	Form · route	Labeler	Product NDC
fesoterodine fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1168
fesoterodine fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1169
fesoterodine fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-479