What is NDC 46708-176?

46708-176 is the product NDC for Fesoterodine Fumarate, Fesoterodine fumarate 8 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fesoterodine Fumarate?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fesoterodine Fumarate NDC 46708-176

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-176Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0176Add 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
46708-176-10	4670801761046708017610	100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-176-10)Marketed from Jan 6, 2023
46708-176-30	4670801763046708017630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-30)Marketed from Jan 6, 2023
46708-176-90	4670801769046708017690	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-90)Marketed from Jan 6, 2023
46708-176-91	4670801769146708017691	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-176-91)Marketed from Jan 6, 2023

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, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204973
Marketing start: Jan 6, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 46708-176_571147f2-e182-44b5-9d0b-ecfc3265cc2dSPL ID 571147f2-e182-44b5-9d0b-ecfc3265cc2dSPL set ID 571147f2-e182-44b5-9d0b-ecfc3265cc2dRxCUI 810071, 810077UNII EOS72165S7UPC 0346708175306

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

N446708017610 followed by a unit qualifier and the quantity

Package 46708-0176-10. 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 Jan 30, 2023.

Indications (excerpt from the label)

Fesoterodine fumarate extended-release tablets are indicated for the treatment of: • Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-176

What is NDC 46708-176?: 46708-176 is the product NDC for Fesoterodine Fumarate, Fesoterodine fumarate 8 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fesoterodine Fumarate.
What is the active ingredient?: Fesoterodine fumarate.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fesoterodine Fumarate?: 21 other product NDCs are listed under this name. See all Fesoterodine Fumarate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fesoterodine Fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Film coated, Extended releaseOral	NorthStar RxLLC	72603-413	72603-0413-01
Fesoterodine Fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Film coated, Extended releaseOral	NorthStar RxLLC	72603-414	72603-0414-01
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-033	31722-0033-3031722-0033-90
Fesoterodine Fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Film coated, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-034	31722-0034-3031722-0034-90
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-175	46708-0175-1046708-0175-3046708-0175-90+1 more
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-175	62332-0175-1062332-0175-3062332-0175-90+1 more
Fesoterodine Fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-176	62332-0176-1062332-0176-3062332-0176-90+1 more
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-369	65162-0369-0365162-0369-09
Fesoterodine Fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-370	65162-0370-0365162-0370-09
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	65862-766	65862-0766-30

All 22 Fesoterodine Fumarate NDCs

Other NDCs under ANDA 204973

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

FDA NDC Directory listings under ANDA 204973
Product	Strength	Form · route	Labeler	Product NDC
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-175
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-175
Fesoterodine Fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-176