isradipine

Generic: isradipine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name isradipine
Generic Name isradipine
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

isradipine 5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 16252-540
Product ID 16252-540_ac19e8fb-dc66-4e27-8109-d9ac5bf9b8e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077317
Listing Expiration 2026-12-31
Marketing Start 2006-01-05

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 16252540
Hyphenated Format 16252-540

Supplemental Identifiers

RxCUI
197848 197849
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 ANDA077317 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (16252-540-01)
source: ndc

Packages (1)

16252-540-01 100 CAPSULE in 1 BOTTLE (16252-540-01)

Ingredients (1)

isradipine (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": "ac19e8fb-dc66-4e27-8109-d9ac5bf9b8e9", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["YO1UK1S598"], "rxcui": ["197848", "197849"], "spl_set_id": ["bf3425e0-428d-4bdb-ac9a-3b9d483df83a"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16252-540-01)", "package_ndc": "16252-540-01", "marketing_start_date": "20060105"}], "brand_name": "Isradipine", "product_id": "16252-540_ac19e8fb-dc66-4e27-8109-d9ac5bf9b8e9", "dosage_form": "CAPSULE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "16252-540", "generic_name": "Isradipine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isradipine", "active_ingredients": [{"name": "ISRADIPINE", "strength": "5 mg/1"}], "application_number": "ANDA077317", "marketing_category": "ANDA", "marketing_start_date": "20060105", "listing_expiration_date": "20261231"}