What is NDC 65862-861?

65862-861 is the product NDC for Darifenacin, Darifenacin hydrobromide 7.5 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Darifenacin?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Darifenacin NDC 65862-861 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-861Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0861Add 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
65862-861-05	6586208610565862086105	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-05)Marketed from Sep 19, 2016
65862-861-30	6586208613065862086130	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-30)Marketed from Sep 19, 2016
65862-861-90	6586208619065862086190	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-90)Marketed from Sep 19, 2016
65862-861-99	6586208619965862086199	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-99)Marketed from Sep 19, 2016

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): Darifenacin
Generic name (nonproprietary): darifenacin
Active ingredients: Darifenacin hydrobromide — 7.5 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206743
Marketing start: Sep 19, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 65862-861_389b20f0-64d5-46f6-bb3b-74feb1a9898bSPL ID 389b20f0-64d5-46f6-bb3b-74feb1a9898bSPL set ID 28ed5b58-46dd-4140-a877-4b422f780a94RxCUI 485421, 485423UNII CR02EYQ8GVUPC 0365862862303
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

N465862086105 followed by a unit qualifier and the quantity

Package 65862-0861-05. 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 Apr 19, 2024.

Indications (excerpt from the label)

Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-861

What is NDC 65862-861?: 65862-861 is the product NDC for Darifenacin, Darifenacin hydrobromide 7.5 mg/1 tablet, film coated, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Darifenacin.
What is the active ingredient?: Darifenacin hydrobromide.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Darifenacin?: 15 other product NDCs are listed under this name. See all Darifenacin 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 Darifenacin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-223	46708-0223-0846708-0223-3046708-0223-90+1 more
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-224	46708-0224-0846708-0224-3046708-0224-90+1 more
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-223	62332-0223-0862332-0223-3062332-0223-90+1 more
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-224	62332-0224-0862332-0224-3062332-0224-90+1 more
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-276	33342-0276-0733342-0276-1033342-0276-12
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-277	33342-0277-0733342-0277-1033342-0277-12
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Torrent Pharmaceuticals Limited	13668-202	13668-0202-0513668-0202-3013668-0202-90
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Torrent Pharmaceuticals Limited	13668-203	13668-0203-0513668-0203-3013668-0203-90
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2570	72162-2570-03
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2571	72162-2571-03

All 16 Darifenacin NDCs

Other NDCs under ANDA 206743

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

FDA NDC Directory listings under ANDA 206743
Product	Strength	Form · route	Labeler	Product NDC
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Film coated, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-767
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Film coated, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-768
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	65862-862