repaglinide

Generic: repaglinide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name repaglinide
Generic Name repaglinide
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

repaglinide 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-671
Product ID 65862-671_54d938ac-ebf2-49d0-8056-f65d8aadfb98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203820
Listing Expiration 2026-12-31
Marketing Start 2014-01-22

Pharmacologic Class

Established (EPC)
glinide [epc]
Mechanism of Action
potassium channel antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862671
Hyphenated Format 65862-671

Supplemental Identifiers

RxCUI
200256 200257 200258
UPC
0365862670014 0365862672018 0365862671011
UNII
668Z8C33LU
NUI
N0000175428 N0000175448

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 repaglinide (source: ndc)
Generic Name repaglinide (source: ndc)
Application Number ANDA203820 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-671-01)
  • 500 TABLET in 1 BOTTLE (65862-671-05)
  • 1000 TABLET in 1 BOTTLE (65862-671-99)
source: ndc

Packages (3)

65862-671-01 100 TABLET in 1 BOTTLE (65862-671-01) 65862-671-05 500 TABLET in 1 BOTTLE (65862-671-05) 65862-671-99 1000 TABLET in 1 BOTTLE (65862-671-99)

Ingredients (1)

repaglinide (1 mg/1)

Linked Drug Pages (1)

Repaglinide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "54d938ac-ebf2-49d0-8056-f65d8aadfb98", "openfda": {"nui": ["N0000175428", "N0000175448"], "upc": ["0365862670014", "0365862672018", "0365862671011"], "unii": ["668Z8C33LU"], "rxcui": ["200256", "200257", "200258"], "spl_set_id": ["68064989-47ea-4ed5-a20e-43c4ef6ec271"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-671-01)", "package_ndc": "65862-671-01", "marketing_start_date": "20140122"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-671-05)", "package_ndc": "65862-671-05", "marketing_start_date": "20140122"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-671-99)", "package_ndc": "65862-671-99", "marketing_start_date": "20140122"}], "brand_name": "Repaglinide", "product_id": "65862-671_54d938ac-ebf2-49d0-8056-f65d8aadfb98", "dosage_form": "TABLET", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "65862-671", "generic_name": "Repaglinide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Repaglinide", "active_ingredients": [{"name": "REPAGLINIDE", "strength": "1 mg/1"}], "application_number": "ANDA203820", "marketing_category": "ANDA", "marketing_start_date": "20140122", "listing_expiration_date": "20261231"}