isradipine

Generic: isradipine

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isradipine
Generic Name isradipine
Labeler elite laboratories, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isradipine 2.5 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-910
Product ID 64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077169
Listing Expiration 2026-12-31
Marketing Start 2022-12-28

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850910
Hyphenated Format 64850-910

Supplemental Identifiers

RxCUI
197848 197849
UPC
0364850911016 0364850910019
UNII
YO1UK1S598
NUI
N0000000069 N0000175421 M0006414

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 isradipine (source: ndc)
Generic Name isradipine (source: ndc)
Application Number ANDA077169 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64850-910-01)
  • 500 CAPSULE in 1 BOTTLE (64850-910-05)
source: ndc

Packages (2)

64850-910-01 100 CAPSULE in 1 BOTTLE (64850-910-01) 64850-910-05 500 CAPSULE in 1 BOTTLE (64850-910-05)

Ingredients (1)

isradipine (2.5 mg/1)

Linked Drug Pages (1)

Isradipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "194819ab-8bf2-4f80-b9bb-a1209af1ba21", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0364850911016", "0364850910019"], "unii": ["YO1UK1S598"], "rxcui": ["197848", "197849"], "spl_set_id": ["acf7c376-6cb6-4857-b455-0bf5da29346c"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64850-910-01)", "package_ndc": "64850-910-01", "marketing_start_date": "20221228"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (64850-910-05)", "package_ndc": "64850-910-05", "marketing_start_date": "20221228"}], "brand_name": "Isradipine", "product_id": "64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21", "dosage_form": "CAPSULE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "64850-910", "generic_name": "Isradipine", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isradipine", "active_ingredients": [{"name": "ISRADIPINE", "strength": "2.5 mg/1"}], "application_number": "ANDA077169", "marketing_category": "ANDA", "marketing_start_date": "20221228", "listing_expiration_date": "20261231"}