FDA.reportPublic FDA data

Cyclopentolate Hydrochloride

Product NDC
24208-735
11-digit product format
242080735
Labeler code
24208
Product ID
24208-735_34fff06e-fa45-478a-b136-e019483fa07d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclopentolate Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA040075
Marketing category
ANDA
Marketing start
1994-04-29
Substance
CYCLOPENTOLATE HYDROCHLORIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOPENTOLATE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii736I6971TE
Rxcui1298066

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
da26936b-2875-4173-812f-99a1f7074052Product name120151215
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-735-01Cyclopentolate Hydrochloride2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS215
24208-735-01Cyclopentolate Hydrochloride1 in 1 CARTONSOLUTION/ DROPS115
24208-735-06Cyclopentolate Hydrochloride1 in 1 CARTONSOLUTION/ DROPS115
24208-735-06Cyclopentolate Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-735-01ML - Milliliter24208-7359c22b6ba-0f8c-45ab-977a-41f5b26f55c412012-07-24
24208-735-06ML - Milliliter24208-7350b3e66cf-eadd-4b04-8349-262bc351a95b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOPENTOLATE HYDROCHLORIDEACTIVE INGREDIENT736I6971TECYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
CYCLOPENTOLATEACTIVE MOIETYI76F4SHP7JCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
WATERINACTIVE INGREDIENT059QF0KO0RCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]9
CYCLOPENTOLATE HYDROCHLORIDEACTIVE INGREDIENT736I6971TECYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
CYCLOPENTOLATEACTIVE MOIETYI76F4SHP7JCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
CYCLOPENTOLATE HYDROCHLORIDEACTIVE INGREDIENT736I6971TECYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
CYCLOPENTOLATEACTIVE MOIETYI76F4SHP7JCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-735CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]15Current NDC, Legacy NDC, 4 package rows20221005_ad85b220-6003-4a78-b900-5195ceaf0fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298066cyclopentolate HCl 1 % Ophthalmic SolutionPSNad85b220-6003-4a78-b900-5195ceaf0fd515
1298066cyclopentolate hydrochloride 10 MG/ML Ophthalmic SolutionSCDad85b220-6003-4a78-b900-5195ceaf0fd515
1298066cyclopentolate hydrochloride 1 % Ophthalmic SolutionSYad85b220-6003-4a78-b900-5195ceaf0fd515
1298066cyclopentolate HCl 1 % Ophthalmic SolutionPSN4d4131f8-79d0-40a4-87e8-667fd2db8d7a1
1298066cyclopentolate hydrochloride 10 MG/ML Ophthalmic SolutionSCD4d4131f8-79d0-40a4-87e8-667fd2db8d7a1
1298066cyclopentolate hydrochloride 1 % Ophthalmic SolutionSY4d4131f8-79d0-40a4-87e8-667fd2db8d7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-735-01242080735011 BOTTLE, DROPPER in 1 CARTON (24208-735-01) / 2 mL in 1 BOTTLE, DROPPER1994-04-290000-00-00NoNoCurrent
24208-735-06242080735061 BOTTLE, DROPPER in 1 CARTON (24208-735-06) / 15 mL in 1 BOTTLE, DROPPER1994-04-290000-00-00NoNoCurrent