amlodipine besylate

Generic: amlodipine besylate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-902
Product ID 67877-902_700631a3-7f24-4699-a195-0a6a7fae214e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078925
Listing Expiration 2026-12-31
Marketing Start 2025-12-06

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877902
Hyphenated Format 67877-902

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0367877901053 0367877902104 0367877900902
UNII
864V2Q084H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amlodipine besylate (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA078925 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets Amlodipine besylate tablets, USP 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are supplied as white to off white, round, flat, beveled edge tablets with ‘A 2’ debossed on one side and plain on other side and supplied as follows: NDC 67877-900-90 Bottle of 90 NDC 67877-900-05 Bottle of 500 NDC 67877-900-10 Bottle of 1000 NDC 67877-900-38 Carton of 100 tablets (10x10 Unit-dose) 5 mg Tablets Amlodipine besylate tablets, USP 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off white, round, flat, beveled edge tablets with ‘A 5’ debossed on one side and plain on other side and supplied as follows: NDC 67877-901-90 Bottle of 90 NDC 67877-901-05 Bottle of 500 NDC 67877-901-10 Bottle of 1000 NDC 67877-901-38 Carton of 100 tablets (10x10 Unit-dose) 10 mg Tablets Amlodipine besylate tablets, USP 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off white, round, flat, beveled edge tablets with ‘A l 0' debossed on one side and plain on other side and supplied as follows: NDC 67877-902-90 Bottle of 90 NDC 67877-902-05 Bottle of 500 NDC 67877-902-10 Bottle of 1000 NDC 67877-902-38 Carton of 100 tablets (10x10 Unit-dose) Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature), and dispense in tight, light resistant container (USP). Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA. Distributed by: Ascend Laboratories, LLC Bedminster, NJ 07921 Revised Date: February, 2025 For Patient Information, please visit: www.ascendlaboratories.com/pti/amlodipinetabs.pdf
  • PRINCIPAL DISPLAY PANEL - 2.5 mg Tablets NDC -67877-900-90 Bottle of 90 tablets Rx Only amlodipine-25mg-90tabs-cont
  • PRINCIPAL DISPLAY PANEL - 5 mg Tablets NDC -67877-901-05 Bottle of 500 tablets Rx Only amlodipine-5mg-500tabs-cont
  • PRINCIPAL DISPLAY PANEL - 10 mg Tablets NDC -67877-902-10 Bottle of 1000 tablets Rx Only amlodipine-10mg-1000tabs-cont
source: label

Packages (0)

No package records.

Ingredients (1)

amlodipine besylate (10 mg/1)

Linked Drug Pages (1)

Amlodipine Besylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "700631a3-7f24-4699-a195-0a6a7fae214e", "openfda": {"upc": ["0367877901053", "0367877902104", "0367877900902"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["2b0bcb95-dc85-46f7-8b69-ca55cd58b30e"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Amlodipine Besylate", "product_id": "67877-902_700631a3-7f24-4699-a195-0a6a7fae214e", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "67877-902", "generic_name": "Amlodipine besylate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078925", "marketing_category": "ANDA", "marketing_start_date": "20251206", "listing_expiration_date": "20261231"}