nebivolol

Generic: nebivolol

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nebivolol
Generic Name nebivolol
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nebivolol hydrochloride 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3527
Product ID 70518-3527_48be4213-e2e2-10b7-e063-6294a90aee17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203828
Listing Expiration 2027-12-31
Marketing Start 2022-09-20

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183527
Hyphenated Format 70518-3527

Supplemental Identifiers

RxCUI
387013
UNII
JGS34J7L9I

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 nebivolol (source: ndc)
Generic Name nebivolol (source: ndc)
Application Number ANDA203828 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3527-0)
source: ndc

Packages (1)

70518-3527-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-3527-0)

Ingredients (1)

nebivolol hydrochloride (5 mg/1)

Linked Drug Pages (1)

Nebivolol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48be4213-e2e2-10b7-e063-6294a90aee17", "openfda": {"unii": ["JGS34J7L9I"], "rxcui": ["387013"], "spl_set_id": ["3745fc9d-cd3f-4877-bef0-81d9a9a05786"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3527-0)", "package_ndc": "70518-3527-0", "marketing_start_date": "20220920"}], "brand_name": "Nebivolol", "product_id": "70518-3527_48be4213-e2e2-10b7-e063-6294a90aee17", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70518-3527", "generic_name": "Nebivolol", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nebivolol", "active_ingredients": [{"name": "NEBIVOLOL HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203828", "marketing_category": "ANDA", "marketing_start_date": "20220920", "listing_expiration_date": "20271231"}