FDA.reportPublic FDA data

NDC 0054-8596-11 - Meperidine Hydrochloride

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
0054-8596
Requested NDC
0054-8596-11
Package NDCs from labels
0054-8596-11
Manufacturer
Boehringer Ingelheim
Effective date
2006-05-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Meperidine Hydrochloride - Boehringer IngelheimBoehringer Ingelheim2006-05-16Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-4596-25Meperidine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1001
0054-8596-11Meperidine Hydrochloride25 in 1 BLISTER PACKTABLET251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-8596MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]12 package rows20060621_9C4F12E5-5E69-44D4-81A5-BD72C375EEF5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
meperidine hydrochlorideACTIVE INGREDIENTN8E7F7Q170MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
meperidineACTIVE MOIETY9E338QE28FMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
croscarmellose sodiumINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
lactose monohydrateINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
maltolINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
micro-crystalline celluloseINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
povidoneINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
pregelatinized starchINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
sorbitol solutionINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
starch (corn)INACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
waterINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1

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 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.b31d1308-28c3-43f4-e0a6-2f3ed76b89752026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N8E7F7Q170
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.15bc51a8-1e24-4d33-9a2f-05a41c29acf02026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA088744
ndc (package): 0054-4596-25
ndc (package): 0054-4595-25
ndc (package): 0054-3545-63
ndc (package): 0054-8595-11
ndc (product): 0054-4596
ndc (product): 0054-8595
ndc (product): 0054-4595
ndc (product): 0054-3545
rxcui: 861467
rxcui: 861479
rxcui: 861455
spl id: 677fb454-d83d-4c3c-b095-a58a1c4781b9
spl set id: 15bc51a8-1e24-4d33-9a2f-05a41c29acf0
unii: N8E7F7Q170
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEGenus Lifesciences Inc.792fefda-6cc4-4709-b902-fd9787fc310a2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861467
unii: N8E7F7Q170
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEEPIC PHARMA, LLCfae5cc34-5917-4445-9516-25f97ffca8db2025-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861467
rxcui: 861455
unii: N8E7F7Q170
MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e0e998da-f056-4fce-be8e-ed60cf3b461b2024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: N8E7F7Q170

Reported adverse events (FAERS/openFDA)#

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