repaglinide

Generic: repaglinide

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name repaglinide
Generic Name repaglinide
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

repaglinide 1 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-249
Product ID 33342-249_7a93246c-9323-40c4-b590-a40dcb133c8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207209
Listing Expiration 2026-12-31
Marketing Start 2023-03-22

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 33342249
Hyphenated Format 33342-249

Supplemental Identifiers

RxCUI
200256 200257 200258
UPC
0333342248114 0333342249449 0333342250117 0333342250445 0333342249111
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 ANDA207209 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (33342-249-11)
  • 1000 TABLET in 1 BOTTLE (33342-249-44)
source: ndc

Packages (2)

33342-249-11 100 TABLET in 1 BOTTLE (33342-249-11) 33342-249-44 1000 TABLET in 1 BOTTLE (33342-249-44)

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": "7a93246c-9323-40c4-b590-a40dcb133c8c", "openfda": {"nui": ["N0000175428", "N0000175448"], "upc": ["0333342248114", "0333342249449", "0333342250117", "0333342250445", "0333342249111"], "unii": ["668Z8C33LU"], "rxcui": ["200256", "200257", "200258"], "spl_set_id": ["7a93246c-9323-40c4-b590-a40dcb133c8c"], "pharm_class_epc": ["Glinide [EPC]"], "pharm_class_moa": ["Potassium Channel Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-249-11)", "package_ndc": "33342-249-11", "marketing_start_date": "20230322"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (33342-249-44)", "package_ndc": "33342-249-44", "marketing_start_date": "20230322"}], "brand_name": "Repaglinide", "product_id": "33342-249_7a93246c-9323-40c4-b590-a40dcb133c8c", "dosage_form": "TABLET", "pharm_class": ["Glinide [EPC]", "Potassium Channel Antagonists [MoA]"], "product_ndc": "33342-249", "generic_name": "Repaglinide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Repaglinide", "active_ingredients": [{"name": "REPAGLINIDE", "strength": "1 mg/1"}], "application_number": "ANDA207209", "marketing_category": "ANDA", "marketing_start_date": "20230322", "listing_expiration_date": "20261231"}