nisoldipine

Generic: nisoldipine

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name nisoldipine
Generic Name nisoldipine
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nisoldipine 34 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-475
Product ID 66993-475_a999e1d0-199c-4631-8a51-8dc27e05f3ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020356
Marketing Start 2012-02-27
Marketing End 2027-05-31

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]
Physiologic Effect
decreased blood pressure [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993475
Hyphenated Format 66993-475

Supplemental Identifiers

RxCUI
763519 763589 790489
UNII
4I8HAB65SZ
NUI
N0000175421 M0006414 N0000000069 N0000178477

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 nisoldipine (source: ndc)
Generic Name nisoldipine (source: ndc)
Application Number NDA020356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 34 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (66993-475-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

66993-475-02 1 BOTTLE in 1 CARTON (66993-475-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

nisoldipine (34 mg/1)

Linked Drug Pages (1)

Nisoldipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a999e1d0-199c-4631-8a51-8dc27e05f3ab", "openfda": {"nui": ["N0000175421", "M0006414", "N0000000069", "N0000178477"], "unii": ["4I8HAB65SZ"], "rxcui": ["763519", "763589", "790489"], "spl_set_id": ["8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_pe": ["Decreased Blood Pressure [PE]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66993-475-02)  / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "66993-475-02", "marketing_end_date": "20270531", "marketing_start_date": "20120227"}], "brand_name": "Nisoldipine", "product_id": "66993-475_a999e1d0-199c-4631-8a51-8dc27e05f3ab", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Decreased Blood Pressure [PE]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "66993-475", "generic_name": "Nisoldipine", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nisoldipine", "active_ingredients": [{"name": "NISOLDIPINE", "strength": "34 mg/1"}], "application_number": "NDA020356", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20270531", "marketing_start_date": "20120227"}