FDA.reportPublic FDA data

Application 040169

Type
ANDA
Sponsor
GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDESYRUP;ORAL10MG/5MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040169-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAARS2005-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040169-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040169-001DICYCLOMINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAARS2005-03-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040169-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEPar Health USA, LLCbb099db9-f635-4a64-8892-6236971dec452026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040169
application number: ANDA040169
ndc (product): 0603-1161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-1161dicyclomine hydrochloridedicyclomine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-1161dicyclomine hydrochloridedicyclomine hydrochloridePar PharmaceuticalANDACurrent
17856-1161dicyclomine hydrochloridedicyclomine hydrochlorideAtlantic Biologicals CorpsANDACurrent
46672-657dicyclomine hydrochloridedicyclomine hydrochlorideMikart, Inc.ANDACurrent
53703-800Dicyclomine HydrochlorideDicyclomine HydrochlorideEntera Health, Inc.ANDACurrent
63629-2179dicyclomine hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent
63629-2179dicyclomine hydrochloridedicyclomine hydrochlorideBryant Ranch PrepackANDACurrent
68151-1161dicyclomine hydrochloridedicyclomine hydrochlorideCarilion Materials ManagementANDACurrent