What is NDC 71610-277?

71610-277 is the product NDC for Oxybutynin Chloride, Oxybutynin chloride 5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 Chloride?

79 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxybutynin Chloride NDC 71610-277 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-277Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0277Add 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
71610-277-30	7161002773071610027730	30 TABLET in 1 BOTTLE (71610-277-30)Marketed from May 31, 2023
71610-277-53	7161002775371610027753	60 TABLET in 1 BOTTLE (71610-277-53)Marketed from May 13, 2019
71610-277-60	7161002776071610027760	90 TABLET in 1 BOTTLE (71610-277-60)Marketed from May 13, 2019
71610-277-80	7161002778071610027780	180 TABLET in 1 BOTTLE (71610-277-80)Marketed from May 13, 2019
71610-277-92	7161002779271610027792	270 TABLET in 1 BOTTLE (71610-277-92)Marketed from May 13, 2019

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 Chloride
Generic name (nonproprietary): oxybutynin chloride
Active ingredients: Oxybutynin chloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209823
Marketing start: Oct 23, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 71610-277_b28dba2b-b19b-469e-98d8-54e87e3800e3SPL ID b28dba2b-b19b-469e-98d8-54e87e3800e3SPL set ID d2bb6927-5fbf-49ca-a891-d701bff1c812RxCUI 863664UNII 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

N471610027730 followed by a unit qualifier and the quantity

Package 71610-0277-30. 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 May 31, 2023.

Indications (excerpt from the label)

INDICATIONS & USAGE Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-277

What is NDC 71610-277?: 71610-277 is the product NDC for Oxybutynin Chloride, Oxybutynin chloride 5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oxybutynin Chloride.
What is the active ingredient?: Oxybutynin chloride.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 Chloride?: 79 other product NDCs are listed under this name. See all Oxybutynin Chloride 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 Chloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxybutynin Chloride	Oxybutynin chloride 2.5 mg/1	TabletOral	TruPharma LLC	52817-261	52817-0261-10
Oxybutynin Chloride	Oxybutynin chloride 2.5 mg/1	TabletOral	RISING PHARMA HOLDINGS, INC.	64980-734	64980-0734-01
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Coupler LLC	67046-1381	67046-1381-03
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-913	23155-0913-0123155-0913-0523155-0913-10
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	RISING PHARMA HOLDINGS, INC.	64980-679	64980-0679-0164980-0679-1064980-0679-50
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-8078	50090-8078-0050090-8078-0150090-8078-03
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	American Health Packaging	60687-899	60687-0899-01
Oxybutynin Chloride	Oxybutynin chloride 2.5 mg/1	TabletOral	Strides Pharma Science Limited	64380-190	64380-0190-01
Oxybutynin Chloride	Oxybutynin chloride 15 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1600	67046-1600-03
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1599	67046-1599-03

All 80 Oxybutynin Chloride NDCs

Other NDCs under ANDA 209823

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

FDA NDC Directory listings under ANDA 209823
Product	Strength	Form · route	Labeler	Product NDC
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Major Pharmaceuticals	0904-7027
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-6966
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	A-S Medication Solutions	50090-6967
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-099
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Northwind Health Company, LLC	51655-665
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2632
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	66267-642
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-005
Oxybutynin Chloride	Oxybutynin chloride 5 mg/1	TabletOral	VERITYRX, LLC	83939-0022