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 1 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.6d7e73b0-3f7e-462f-92eb-cc82919c80952026-09-10Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.62be6437-db8c-431b-8e5f-780487cf2d432026-09-09Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.e67ad329-6395-4fa0-a898-f13959034e262026-09-04Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.7ff96d1f-fb87-4244-a697-1d93e10eb7382026-08-21Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEMajor Pharmaceuticals5eee0dff-d157-4534-adfb-c035b7042c072026-08-20Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug594b6832-a31c-4de2-e063-6294a90a05fa2026-08-18Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.2c36b79f-153c-446c-899b-6e28ccff1dc82026-08-18Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug58e713f9-6412-0a1a-e063-6394a90a91b62026-08-13Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC793a3f0c-ea45-4e28-a98a-610cf9eddad82026-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9d249073-0171-4bb0-8cad-13cb3713159f2026-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.de44e605-14a3-4b40-bf1b-2ac857eb7b122026-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDELannett Company, LLCbd2cba10-70ec-4d1f-b46c-53d1de2ee1302026-08-06Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug57e5f041-9a6e-9d0c-e063-6294a90ab54c2026-07-31Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEAdvagen Pharma Ltd.,a66aa5c7-1fde-42fc-9e1f-7f4cc9adac9c2026-07-22Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack3dc0f4f0-ee38-4f9b-abb6-6395215fe5242026-07-16Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack4da6868f-3530-4960-af71-e56439c96e9f2026-07-14Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack34db5a80-f445-41e5-b3c4-4c18abb09c922026-07-14Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy41aed1c9-b32f-3694-e063-6394a90a29e42026-06-25Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAvPAK141d3818-7a87-aaa0-e063-6294a90a48662026-06-23Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1b2d5256-b75d-11f8-e063-6394a90ae9ed2026-06-23Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31

Reported adverse events (FAERS/openFDA)#

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