Prescription drug · ANDA

Amlodipine Besylate NDC 65841-622

Amlodipine besylate 10 mg/1 · Tablet · Oral · Zydus Lifesciences Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)65841-622Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0622Add 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 NDC11-digit (billing)PackageCopy
65841-622-0165841062201100 TABLET in 1 BOTTLE (65841-622-01)Marketed from Sep 21, 2007
65841-622-0565841062205500 TABLET in 1 BOTTLE (65841-622-05)Marketed from Sep 21, 2007
65841-622-166584106221690 TABLET in 1 BOTTLE (65841-622-16)Marketed from Sep 21, 2007
65841-622-776584106227710 BLISTER PACK in 1 CARTON (65841-622-77) / 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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078226
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 65841-622_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

N465841062201 followed by a unit qualifier and the quantity

Package 65841-0622-01. 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 .

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralCardinal Health 107, LLC55154-8093
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralMajor Pharmaceuticals0904-6369
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralMajor Pharmaceuticals0904-6370
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralMajor Pharmaceuticals0904-6371
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-122
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-121
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-123
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralCardinal Health 107, LLC55154-6875
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralCardinal Health 107, LLC55154-6892
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralZydus Lifesciences Limited65841-621
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralZydus Lifesciences Limited65841-620
Amlodipine BesylateAmlodipine besylate 5 mg/1TabletOralSafecor Health LLC48433-156
Amlodipine BesylateAmlodipine besylate 2.5 mg/1TabletOralSafecor Health LLC48433-155
Amlodipine BesylateAmlodipine besylate 10 mg/1TabletOralSafecor Health LLC48433-157

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Amlodipine Besylate NDC 65841-622 | Med-Code