FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct87047-7852DDiscontinued by firm2026-08-03
excluded packagepackage87047-785287047-7852-1DDiscontinued by firm2026-08-03

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
N218643-001CYKLXARTICAINE HYDROCHLORIDEEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD2025-08-15

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218643-001110969222039-03-27U-4423Drug product2026-03-09
N218643-001118263472039-03-27U-4423Drug product2026-03-09
N218643-001124031262039-03-27U-4422Drug product2026-03-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218643-001NP2028-08-15

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
2026-02-19 14:30 UTC2026-02N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-08-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001CYKLXEQ 8% BASESOLUTION/DROPS / OPHTHALMICRLD2025-08-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001110969222039-03-27U-4423Drug product2026-03-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001118263472039-03-27U-4423Drug product2026-03-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001124031262039-03-27U-4422Drug product2026-03-09a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N218643-001NP2028-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218643-001NP2028-08-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218643-001NP2028-08-15a50c72e98297…

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