CYKLX

Product NDC
87047-7852
11-digit product format
870477852
Labeler code
87047
Product ID
87047-7852_453d0158-979d-12a6-e063-6294a90afe7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
articaine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
American Genomics, LLC
Application
NDA218643
Marketing category
NDA
Marketing start
2026-04-02
Substance
ARTICAINE HYDROCHLORIDE
Active strength
80 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTICAINE HYDROCHLORIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQS9014Q792
Rxcui2739743, 2739748

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87047-7852-1CYKLX10 in 1 CARTONSOLUTION/ DROPS104
87047-7852-1CYKLX5 in 1 POUCHSOLUTION/ DROPS54
87047-7852-2CYKLX2 in 1 CARTONSOLUTION/ DROPS24
87047-7852-2CYKLX5 in 1 POUCHSOLUTION/ DROPS54

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739743articaine 8 % Ophthalmic SolutionPSN60e89ad4-8b65-4049-82ba-f34d4836eac04
2739748Cyklx 8 % Ophthalmic SolutionPSN60e89ad4-8b65-4049-82ba-f34d4836eac04
2739748articaine 80 MG/ML Ophthalmic Solution [Cyklx]SBD60e89ad4-8b65-4049-82ba-f34d4836eac04
2739743articaine 80 MG/ML Ophthalmic SolutionSCD60e89ad4-8b65-4049-82ba-f34d4836eac04
2739743articaine (as articaine hydrochloride) 8 % Ophthalmic SolutionSY60e89ad4-8b65-4049-82ba-f34d4836eac04
2739748Cyklx (as articaine hydrochloride) 8 % Ophthalmic SolutionSY60e89ad4-8b65-4049-82ba-f34d4836eac04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87047-7852-18704778520110 POUCH in 1 CARTON (87047-7852-1) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE10 pouch2026-04-02NoNoHistorical
87047-7852-2870477852022 POUCH in 1 CARTON (87047-7852-2) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE2 pouch2026-04-02NoNoHistorical