What is NDC 68382-480?

68382-480 is the product NDC for fesoterodine fumarate, Fesoterodine fumarate 8 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 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	6838204800668382048006	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-06)Marketed from Dec 7, 2017
68382-480-16	6838204801668382048016	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-16)Marketed from Dec 7, 2017
68382-480-77	6838204807768382048077	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.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204946
Marketing start: Dec 7, 2017
Listing expires: Dec 31, 2027
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

Current FDA label (SPL), effective Jan 1, 2025.

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 ) Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2 ) 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. 1.2 Pediatric Neurogenic Detrusor Overactivity Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (ND…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-480

What is NDC 68382-480?: 68382-480 is the product NDC for fesoterodine fumarate, Fesoterodine fumarate 8 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 8 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-176	46708-0176-1046708-0176-3046708-0176-90+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

All 22 fesoterodine fumarate NDCs

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 Pharmaceuticals USA Inc.	68382-479
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