FDA.reportPublic FDA data

NDC 0641-6173-01 - Dicyclomine 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
0641-6173
Requested NDC
0641-6173-01
Package NDCs from labels
0641-6173-01, 0641-6173-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dicyclomine Hydrochloride - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6173-01Dicyclomine Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION26
0641-6173-10Dicyclomine Hydrochloride10 in 1 CARTONINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6173DICYCLOMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20240410_26a94263-46c0-4938-849c-ffb396e48dd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6173-01ML - Milliliter0641-6173ab15b7e1-d21f-4c4b-8c68-2f96570bca3812016-04-04
0641-6173-10ML - Milliliter0641-6173165bccf2-7ebb-4747-b9ae-cc32f2a1916a12016-04-04

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 5 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.20ef2c05-d0a4-405c-e063-6394a90ae6972024-08-30Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAmerican Health Packaging833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe82024-08-29Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack07361f0e-90c7-4531-8d3f-1ec5e7fed40d2024-08-23Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsa16e7b6b-dbc9-463d-9bde-dba4f25589cf2024-08-23Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.40e21575-320f-2ac6-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack4ae8d2fd-a7fb-4cc4-a2cb-720c5a2e20222024-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDECamber Pharmaceuticals, Inc.600f3b80-0303-4f2d-929b-edb689b5b3572024-07-30Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1e0260d0-aaad-aa9f-e063-6294a90a531a2024-07-24Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEFresenius Kabi USA, LLC350ce812-b9a7-401a-9793-55d2e14bb7602024-07-18Warnings, Adverse reactionsExact identifier
rxcui: 991065
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7c75f650-c97d-06fa-e053-2991aa0a43bb2024-07-18Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.51742add-363d-3f9d-e054-00144ff8d46c2024-07-09Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.517646d8-366e-5cf2-e054-00144ff88e882024-07-08Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1b420733-b3b7-e504-e063-6394a90abba72024-06-19Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBionpharma Inc.051bfee3-06cf-309a-e063-6394a90a0bb32024-05-23Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.26a94263-46c0-4938-849c-ffb396e48dd32024-04-09Warnings, Adverse reactionsExact identifier
application number: ANDA040465
ndc (package): 0641-6173-10
ndc (package): 0641-6173-01
ndc (product): 0641-6173
ndc11 (package): 00641617301
rxcui: 991065
spl id: 856c880c-b430-43a3-a225-1fb783b6c0ea
spl set id: 26a94263-46c0-4938-849c-ffb396e48dd3
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEActavis Pharma, Inc.a5937c7b-cdfc-46e6-a0fa-541b24f91d472024-04-01Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEA-S Medication Solutionsb3c9dc85-2c6c-44f0-9c98-02673af934cb2024-02-09Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack226a3a6e-9419-448a-827f-01199b7927622024-02-06Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0d07a460-5cb1-cd4b-e063-6294a90a291d2024-02-05Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc77ef2f7-a846-5e05-e053-2995a90aaae02024-01-22Warnings, Adverse reactionsExact identifier
rxcui: 991065
unii: CQ903KQA31

Reported adverse events (FAERS/openFDA)#

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