FDA.reportPublic FDA data

IHEEZO

Product NDC
82667-300
11-digit product format
826670300
Labeler code
82667
Product ID
82667-300_4dc9b9f7-e722-51ce-e063-6394a90a5219
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chloroprocaine hydrochloride ophthalmic gel
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA216227
Marketing category
NDA
Marketing start
2022-09-27
Substance
CHLOROPROCAINE HYDROCHLORIDE
Active strength
24 mg/800mg
Pharmacologic classes
Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IHEEZO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROPROCAINE HYDROCHLORIDE24 mg/800mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLT7Z1YW11H
Rxcui2613956, 2613961

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5d35ea28-18de-4c43-8b81-d4140e17b91aProduct name120230912
9f0ed4af-e581-4924-816e-213668654c3dProduct name120171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-300-00IHEEZO1 in 1 POUCHGEL14
82667-300-00IHEEZO1 in 1 CARTONGEL14
82667-300-01IHEEZO1 in 1 CARTONGEL14
82667-300-01IHEEZO1 in 1 POUCHGEL14
82667-300-05IHEEZO1 in 1 POUCHGEL14
82667-300-05IHEEZO5 in 1 CARTONGEL54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-300-01EA - Each82667-30060849046-da77-4542-9090-69f1967123f512023-04-07
82667-300-05EA - Each82667-300127bd52f-20d3-4f6a-8fa6-d3e1d1c1546b12026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-300IHEEZO (CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL) GEL [HARROW EYE, LLC]2Current NDC, Legacy NDC, 6 package rows20230224_ea3b2d2c-8b33-d199-e053-2995a90a699c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2613956chloroprocaine hydrochloride 3 % Ophthalmic GelPSNea3b2d2c-8b33-d199-e053-2995a90a699c4
2613961Iheezo 3 % Ophthalmic GelPSNea3b2d2c-8b33-d199-e053-2995a90a699c4
2613961chloroprocaine hydrochloride 0.03 MG/MG Ophthalmic Gel [Iheezo]SBDea3b2d2c-8b33-d199-e053-2995a90a699c4
2613956chloroprocaine hydrochloride 0.03 MG/MG Ophthalmic GelSCDea3b2d2c-8b33-d199-e053-2995a90a699c4
2613956chloroprocaine hydrochloride 24 MG per 800 MG Ophthalmic GelSYea3b2d2c-8b33-d199-e053-2995a90a699c4
2613956chloroprocaine hydrochloride 3 % Ophthalmic GelSYea3b2d2c-8b33-d199-e053-2995a90a699c4
2613961Iheezo 0.03 MG/MG Ophthalmic GelSYea3b2d2c-8b33-d199-e053-2995a90a699c4
2613961Iheezo 24 MG per 800 MG Ophthalmic GelSYea3b2d2c-8b33-d199-e053-2995a90a699c4
2613961Iheezo 3 % Ophthalmic GelSYea3b2d2c-8b33-d199-e053-2995a90a699c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82667-300-00826670300001 POUCH in 1 CARTON (82667-300-00) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL1 pouch2023-03-15YesNoHistorical
82667-300-01826670300011 POUCH in 1 CARTON (82667-300-01) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL1 pouch2022-09-270000-00-00NoNoCurrent
82667-300-05826670300055 POUCH in 1 CARTON (82667-300-05) / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL5 pouch2026-03-02NoNoHistorical