sular

Generic: nisoldipine

Labeler: covis pharma us, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sular
Generic Name nisoldipine
Labeler covis pharma us, inc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nisoldipine 34 mg/1

Manufacturer
Covis Pharma US, Inc

Identifiers & Regulatory

Product NDC 70515-503
Product ID 70515-503_b1f33d4e-acf6-4b44-af7d-83829b7fc808
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020356
Listing Expiration 2026-12-31
Marketing Start 2017-02-03

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 70515503
Hyphenated Format 70515-503

Supplemental Identifiers

RxCUI
763519 763521 763589 763591 790489 790840
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 sular (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 (70515-503-10) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

70515-503-10 1 BOTTLE in 1 CARTON (70515-503-10) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Ingredients (1)

nisoldipine (34 mg/1)

Linked Drug Pages (1)

Sular ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1f33d4e-acf6-4b44-af7d-83829b7fc808", "openfda": {"nui": ["N0000175421", "M0006414", "N0000000069", "N0000178477"], "unii": ["4I8HAB65SZ"], "rxcui": ["763519", "763521", "763589", "763591", "790489", "790840"], "spl_set_id": ["589157fa-d129-4de3-be3d-e0e1c22c5873"], "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": ["Covis Pharma US, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70515-503-10)  / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "70515-503-10", "marketing_start_date": "20170203"}], "brand_name": "Sular", "product_id": "70515-503_b1f33d4e-acf6-4b44-af7d-83829b7fc808", "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": "70515-503", "generic_name": "nisoldipine", "labeler_name": "Covis Pharma US, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sular", "active_ingredients": [{"name": "NISOLDIPINE", "strength": "34 mg/1"}], "application_number": "NDA020356", "marketing_category": "NDA", "marketing_start_date": "20170203", "listing_expiration_date": "20261231"}