What is NDC 62332-224?

62332-224 is the product NDC for Darifenacin, Darifenacin hydrobromide 15 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 62332-224 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-224Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0224Add 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
62332-224-08	6233202240862332022408	8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (62332-224-08)Marketed from Dec 12, 2017
62332-224-30	6233202243062332022430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-224-30)Marketed from Dec 12, 2017
62332-224-90	6233202249062332022490	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-224-90)Marketed from Dec 12, 2017
62332-224-91	6233202249162332022491	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-224-91)Marketed from Dec 12, 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): Darifenacin
Generic name (nonproprietary): darifenacin
Active ingredients: Darifenacin hydrobromide — 15 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207681
Marketing start: Dec 12, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers: Product ID 62332-224_0f406336-e614-4427-89c7-bd26d3792590SPL ID 0f406336-e614-4427-89c7-bd26d3792590SPL set ID 9f6952c8-e547-4f3e-a978-a88d6ea9dc10RxCUI 485421, 485423UNII CR02EYQ8GV
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

N462332022408 followed by a unit qualifier and the quantity

Package 62332-0224-08. 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 Dec 13, 2021.

Indications (excerpt from the label)

Darifenacin is muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are 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 62332-224

What is NDC 62332-224?: 62332-224 is the product NDC for Darifenacin, Darifenacin hydrobromide 15 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Inc.. 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?: Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 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
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Film coated, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-767	16571-0767-0316571-0767-09

All 16 Darifenacin NDCs

Other NDCs under ANDA 207681

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

FDA NDC Directory listings under ANDA 207681
Product	Strength	Form · route	Labeler	Product NDC
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-223
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-224
Darifenacin	Darifenacin hydrobromide 7.5 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-223