What is NDC 65841-621?

65841-621 is the product NDC for Amlodipine Besylate, Amlodipine besylate 5 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amlodipine Besylate?

167 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amlodipine Besylate NDC 65841-621 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-621Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0621Add 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
65841-621-01	6584106210165841062101	100 TABLET in 1 BOTTLE (65841-621-01)Marketed from Sep 21, 2007
65841-621-05	6584106210565841062105	500 TABLET in 1 BOTTLE (65841-621-05)Marketed from Sep 21, 2007
65841-621-16	6584106211665841062116	90 TABLET in 1 BOTTLE (65841-621-16)Marketed from Sep 21, 2007
65841-621-77	6584106217765841062177	10 BLISTER PACK in 1 CARTON (65841-621-77) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 21, 2007

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): Amlodipine Besylate
Generic name (nonproprietary): amlodipine besylate
Active ingredients: Amlodipine besylate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 65841
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078226
Marketing start: Sep 21, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 65841-621_cb1a9e7c-aa86-4596-bc0d-86d8b5750963SPL ID cb1a9e7c-aa86-4596-bc0d-86d8b5750963SPL set ID cacb3551-c579-41cb-bed6-4b4d8b0644fcRxCUI 197361, 308135, 308136UNII 864V2Q084H
Pharmacologic class: Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker

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

N465841062101 followed by a unit qualifier and the quantity

Package 65841-0621-01. 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 25, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 65841-621

What is NDC 65841-621?: 65841-621 is the product NDC for Amlodipine Besylate, Amlodipine besylate 5 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amlodipine Besylate.
What is the active ingredient?: Amlodipine besylate.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amlodipine Besylate?: 167 other product NDCs are listed under this name. See all Amlodipine Besylate 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 Amlodipine Besylate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	American Health Packaging	60687-961	60687-0961-01
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	American Health Packaging	60687-972	60687-0972-01
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Direct_Rx	72189-689	72189-0689-90
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Coupler LLC	67046-1157	67046-1157-03
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-016	87441-0016-01
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-017	87441-0017-01
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Safecor Health LLC	48433-155	48433-0155-20
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Safecor Health LLC	48433-156	48433-0156-20
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Safecor Health LLC	48433-157	48433-0157-20
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4629	70518-4629-0070518-4629-02

All 168 Amlodipine Besylate NDCs

Other NDCs under ANDA 078226

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

FDA NDC Directory listings under ANDA 078226
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Major Pharmaceuticals	0904-6369
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Major Pharmaceuticals	0904-6370
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Major Pharmaceuticals	0904-6371
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Safecor Health LLC	48433-155
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Safecor Health LLC	48433-156
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Safecor Health LLC	48433-157
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-6875
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-6892
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-8093
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-620
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Zydus Lifesciences Limited	65841-622
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-121
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-122
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-123