NDC 0169-0084-83 - Prandin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0169-0084
Requested NDC
0169-0084-83
Package NDCs from labels
0169-0084-81, 0169-0084-82, 0169-0084-80, 0169-0084-83
Manufacturer
Novo Nordisk | Boehringer Ingelheim Pharma GmbH and Co. KG
Effective date
2019-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prandin - Novo Nordisk | Boehringer Ingelheim Pharma GmbH and Co. KGNovo Nordisk | Boehringer Ingelheim Pharma GmbH and Co. KG2019-02-06HUMAN PRESCRIPTION DRUG LABEL
PRANDIN ® (repaglinide) Tablets (0.5, 1, and 2 mg)Physicians Total Care, Inc.2015-05-06HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-0084-81EA - Each0169-00845c383334-ca5d-4703-9d31-c32e4db9069c12012-07-24
0169-0084-83EA - Each0169-0084091fbe41-5b9d-4433-8664-ae100bed479c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
REPAGLINIDEACTIVE INGREDIENT668Z8C33LUPRANDIN (REPAGLINIDE) TABLET [NOVO NORDISK]8
REPAGLINIDEACTIVE MOIETY668Z8C33LUPRANDIN (REPAGLINIDE) TABLET [NOVO NORDISK]8
REPAGLINIDEACTIVE INGREDIENT668Z8C33LUPRANDIN (REPAGLINIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3
REPAGLINIDEACTIVE MOIETY668Z8C33LUPRANDIN (REPAGLINIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RepaglinideREPAGLINIDEBryant Ranch Prepack6ae28683-28cc-408e-90f9-6a3dddfc668d2025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 200256
unii: 668Z8C33LU
RepaglinideREPAGLINIDENorthStar RxLLC7f3118ce-fcbb-4f8b-b1ba-d8cd95e5b6652025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 200258
rxcui: 200256
unii: 668Z8C33LU
RepaglinideREPAGLINIDEBryant Ranch Prepackd85abce4-16da-4231-b28a-6afca04ebf682025-06-05Warnings, Adverse reactionsExact identifier
rxcui: 200258
unii: 668Z8C33LU
RepaglinideREPAGLINIDEChartwell RX, LLCcb995e92-295e-4638-a064-978211f5afe12025-05-02Warnings, Adverse reactionsExact identifier
rxcui: 200258
rxcui: 200256
unii: 668Z8C33LU
RepaglinideREPAGLINIDEBryant Ranch Prepack9f2006d9-e0c0-4cc4-b2c9-84b7d9f771732025-01-23Warnings, Adverse reactionsExact identifier
unii: 668Z8C33LU
RepaglinideREPAGLINIDEBryant Ranch Prepack3b150917-e2fd-4366-af83-ebc1d7297ca92025-01-16Warnings, Adverse reactionsExact identifier
unii: 668Z8C33LU
RepaglinideREPAGLINIDEAmerican Health Packagingdd1d8337-9903-4b8a-a9ea-569e4d134e742024-10-22Warnings, Adverse reactionsExact identifier
rxcui: 200256
unii: 668Z8C33LU
RepaglinideREPAGLINIDEAurobindo Pharma Limited68064989-47ea-4ed5-a20e-43c4ef6ec2712024-05-14Warnings, Adverse reactionsExact identifier
rxcui: 200258
rxcui: 200256
unii: 668Z8C33LU
RepaglinideREPAGLINIDERising Pharma Holdings, Inc.d7673e22-0dbb-4395-ad60-943d249203a12024-05-14Warnings, Adverse reactionsExact identifier
rxcui: 200258
rxcui: 200256
unii: 668Z8C33LU
RepaglinideREPAGLINIDEMacleods Pharmaceuticals Limited7a93246c-9323-40c4-b590-a40dcb133c8c2023-04-04Warnings, Adverse reactionsExact identifier
rxcui: 200258
rxcui: 200256
unii: 668Z8C33LU
814078bb-8c13-a996-e053-2991aa0ab0424c1c212f-71a5-4dd3-81b2-cd9e2148774c2019-02-06Warnings, Adverse reactionsExact identifier
spl id: 814078bb-8c13-a996-e053-2991aa0ab042
spl set id: 4c1c212f-71a5-4dd3-81b2-cd9e2148774c
f04083e0-111f-455c-ab72-35303192530a034c35a5-c037-4ad8-82d1-aec4feac4c972015-05-06Adverse reactionsExact identifier
spl id: f04083e0-111f-455c-ab72-35303192530a
spl set id: 034c35a5-c037-4ad8-82d1-aec4feac4c97

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.