repaglinide

Generic: repaglinide

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name repaglinide
Generic Name repaglinide
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

repaglinide .5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-946
Product ID 62135-946_342983dc-ded9-2234-e063-6294a90ac97f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078555
Listing Expiration 2026-12-31
Marketing Start 2013-11-22

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 62135946
Hyphenated Format 62135-946

Supplemental Identifiers

RxCUI
200256 200257 200258
UPC
0362135948900 0362135947903 0362135946906
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 ANDA078555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (62135-946-90)
source: ndc

Packages (1)

62135-946-90 90 TABLET in 1 BOTTLE (62135-946-90)

Ingredients (1)

repaglinide (.5 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": "342983dc-ded9-2234-e063-6294a90ac97f", "openfda": {"nui": ["N0000175428", "N0000175448"], "upc": ["0362135948900", "0362135947903", "0362135946906"], "unii": ["668Z8C33LU"], "rxcui": ["200256", "200257", "200258"], "spl_set_id": ["cb995e92-295e-4638-a064-978211f5afe1"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-946-90)", "package_ndc": "62135-946-90", "marketing_start_date": "20250424"}], "brand_name": "Repaglinide", "product_id": "62135-946_342983dc-ded9-2234-e063-6294a90ac97f", "dosage_form": "TABLET", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "62135-946", "generic_name": "Repaglinide", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Repaglinide", "active_ingredients": [{"name": "REPAGLINIDE", "strength": ".5 mg/1"}], "application_number": "ANDA078555", "marketing_category": "ANDA", "marketing_start_date": "20131122", "listing_expiration_date": "20261231"}