FDA.reportPublic FDA data

dicyclomine hydrochloride

Product NDC
63629-2179
11-digit product format
636292179
Labeler code
63629
Product ID
63629-2179_22154b09-793e-49c7-a7e7-e3949261a4db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040169
Marketing category
ANDA
Marketing start
2005-06-23
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-2179DDiscontinued by firm2026-07-31
excluded packagepackage63629-217963629-2179-1DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2179-1ML - Milliliter63629-21791291fcba-6b23-43d7-8b43-405093d8f52712021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2179-163629217901473 mL in 1 BOTTLE, PLASTIC (63629-2179-1) 473 ml2021-03-120000-00-00NoNoCurrent