What is NDC 68382-255?

68382-255 is the product NDC for oxybutynin, Oxybutynin chloride 5 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 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 oxybutynin?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

oxybutynin NDC 68382-255 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-255Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0255Add 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
68382-255-01	6838202550168382025501	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-01)Marketed from Aug 10, 2017
68382-255-05	6838202550568382025505	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-05)Marketed from Aug 10, 2017
68382-255-06	6838202550668382025506	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-06)Marketed from Aug 10, 2017
68382-255-14	6838202551468382025514	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-14)Marketed from Aug 10, 2017
68382-255-16	6838202551668382025516	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-255-16)Marketed from Aug 10, 2017
68382-255-77	6838202557768382025577	10 BLISTER PACK in 1 CARTON (68382-255-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-255-30)Marketed from Aug 10, 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): oxybutynin
Generic name (nonproprietary): oxybutynin
Active ingredients: Oxybutynin chloride — 5 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 202332
Marketing start: Aug 10, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 68382-255_f54e4d4e-91be-4e10-a446-57ed5e1843a1SPL ID f54e4d4e-91be-4e10-a446-57ed5e1843a1SPL set ID c042bf06-79a3-4dc7-ae05-3ef3cfae9d44RxCUI 863619, 863628, 863636UNII L9F3D9RENQ
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

N468382025501 followed by a unit qualifier and the quantity

Package 68382-0255-01. 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 Nov 7, 2023.

Indications (excerpt from the label)

Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 ) Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). ( 1 ) Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended release tablets are also indicated for the treatment of pediatric patients…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-255

What is NDC 68382-255?: 68382-255 is the product NDC for oxybutynin, Oxybutynin chloride 5 mg/1 tablet, film coated, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: oxybutynin.
What is the active ingredient?: Oxybutynin chloride.
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 oxybutynin?: 9 other product NDCs are listed under this name. See all oxybutynin 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 oxybutynin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
oxybutynin	Oxybutynin chloride 5 mg/1	Tablet, Film coated, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8219	00615-8219-39
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8220	00615-8220-39
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-5353	50090-5353-00
oxybutynin	Oxybutynin chloride 5 mg/1	Tablet, Film coated, Extended releaseOral	Redpharm Drug	67296-2335	67296-2335-03
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-256	68382-0256-0168382-0256-0568382-0256-06+3 more
oxybutynin	Oxybutynin chloride 15 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-257	68382-0257-0168382-0257-0568382-0257-06+3 more
oxybutynin	Oxybutynin chloride 5 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1086	70771-1086-0170771-1086-0370771-1086-04+3 more
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1087	70771-1087-0170771-1087-0370771-1087-04+3 more
oxybutynin	Oxybutynin chloride 15 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1088	70771-1088-0170771-1088-0370771-1088-04+3 more

Other NDCs under ANDA 202332

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

FDA NDC Directory listings under ANDA 202332
Product	Strength	Form · route	Labeler	Product NDC
oxybutynin	Oxybutynin chloride 5 mg/1	Tablet, Film coated, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8219
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8220
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-5353
oxybutynin	Oxybutynin chloride 5 mg/1	Tablet, Film coated, Extended releaseOral	Redpharm Drug	67296-2335
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-256
oxybutynin	Oxybutynin chloride 15 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-257
oxybutynin	Oxybutynin chloride 5 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1086
oxybutynin	Oxybutynin chloride 10 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1087
oxybutynin	Oxybutynin chloride 15 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	70771-1088