FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
43063-045
11-digit product format
430630045
Labeler code
43063
Product ID
43063-045_2b247a51-9783-e240-e063-6294a90a8907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA085223
Marketing category
ANDA
Marketing start
1986-07-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-045-04Dicyclomine Hydrochloride4 in 1 BOTTLE, PLASTICTABLET432
43063-045-06Dicyclomine Hydrochloride6 in 1 BOTTLE, PLASTICTABLET632
43063-045-20Dicyclomine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET2032
43063-045-30Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET3032
43063-045-60Dicyclomine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET6032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-045-04EA - Each43063-0452d0b23f1-99eb-4ac9-bae5-5f7145696c1f12012-07-24
43063-045-06EA - Each43063-045e83a71e1-23c3-43ae-bfe1-49f33a9a8a2212012-07-24
43063-045-20EA - Each43063-04566355826-4901-47d1-a227-dc37faa91bf612018-06-11
43063-045-30EA - Each43063-0457f76292a-14a5-4ed4-afb1-7cb0fa81da9012018-06-11
43063-045-60EA - Each43063-0455097b35e-01e5-4caa-bdb9-68f22822984b12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-045DICYCLOMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]32Current NDC, Legacy NDC, 5 package rows20250109_da0e1f63-cb90-4c2a-908f-7d81e672be10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNda0e1f63-cb90-4c2a-908f-7d81e672be1032
991086dicyclomine hydrochloride 20 MG Oral TabletSCDda0e1f63-cb90-4c2a-908f-7d81e672be1032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-045-04430630045044 TABLET in 1 BOTTLE, PLASTIC (43063-045-04) 4 tablet2008-12-220000-00-00NoNoCurrent
43063-045-06430630045066 TABLET in 1 BOTTLE, PLASTIC (43063-045-06) 6 tablet2013-09-170000-00-00NoNoCurrent
43063-045-204306300452020 TABLET in 1 BOTTLE, PLASTIC (43063-045-20) 20 tablet2013-09-170000-00-00NoNoCurrent
43063-045-304306300453030 TABLET in 1 BOTTLE, PLASTIC (43063-045-30) 30 tablet2013-08-070000-00-00NoNoCurrent
43063-045-604306300456060 TABLET in 1 BOTTLE, PLASTIC (43063-045-60) 60 tablet2014-04-140000-00-00NoNoCurrent