What is NDC 46708-223?

46708-223 is the product NDC for Darifenacin, Darifenacin hydrobromide 7.5 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-223 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-223Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0223Add 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
46708-223-08	4670802230846708022308	8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08)Marketed from Dec 12, 2017
46708-223-30	4670802233046708022330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30)Marketed from Dec 12, 2017
46708-223-90	4670802239046708022390	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-90)Marketed from Dec 12, 2017
46708-223-91	4670802239146708022391	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-91)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 — 7.5 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
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 46708-223_70d8a245-0125-4c31-b941-2137d96c43c3SPL ID 70d8a245-0125-4c31-b941-2137d96c43c3SPL set ID da7c2732-232c-4e71-92d9-577ef8617f56RxCUI 485421, 485423UNII CR02EYQ8GVUPC 0346708224301, 0346708223304
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

N446708022308 followed by a unit qualifier and the quantity

Package 46708-0223-08. 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 Jan 30, 2023.

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 46708-223

What is NDC 46708-223?: 46708-223 is the product NDC for Darifenacin, Darifenacin hydrobromide 7.5 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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
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 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
Darifenacin	Darifenacin hydrobromide 15 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-224