Phospholine Iodide

Product NDC
48102-053
11-digit product format
481020053
Labeler code
48102
Product ID
48102-053_66abcfcf-b16e-4181-b1db-96bfba0ab95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
echothiophate iodide for ophthalmic solution
Dosage form
KIT
Route
OPHTHALMIC
Labeler
Fera Pharmaceuticals, LLC
Application
NDA011963
Marketing category
NDA
Marketing start
2022-06-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui205739, 310049

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
54d38512-5b7a-d254-ef1b-3c043e7acd6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48102-053-05Phospholine Iodide1 in 1 CARTONKIT15
48102-054-05Phospholine Iodide6.25 mL in 1 BOTTLEPOWDER, FOR SOLUTION6.25 mL6.25 mg in 5mL5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48102-053-05ML - Milliliter48102-05370b4f94e-1087-461b-9fdf-6c5737986a0812022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48102-053PHOSPHOLINE IODIDE (ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION) KIT [FERA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240913_8afc8951-db76-4f27-8752-7c0d6aa47244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310049echothiophate iodide 0.125 % Ophthalmic SolutionPSN8afc8951-db76-4f27-8752-7c0d6aa472445
205739Phospholine Iodide 0.125 % Ophthalmic SolutionPSN8afc8951-db76-4f27-8752-7c0d6aa472445
205739echothiophate iodide 1.25 MG/ML Ophthalmic Solution [Phospholine Iodide]SBD8afc8951-db76-4f27-8752-7c0d6aa472445
310049echothiophate iodide 1.25 MG/ML Ophthalmic SolutionSCD8afc8951-db76-4f27-8752-7c0d6aa472445
310049echothiophate iodide 0.125 % Ophthalmic SolutionSY8afc8951-db76-4f27-8752-7c0d6aa472445
205739Phospholine Iodide 0.125 % Ophthalmic SolutionSY8afc8951-db76-4f27-8752-7c0d6aa472445
205739Phospholine Iodide 1.25 MG/ML Ophthalmic SolutionSY8afc8951-db76-4f27-8752-7c0d6aa472445
205739Phospholine Iodide 6.25 MG per 5 ML Ophthalmic SolutionSY8afc8951-db76-4f27-8752-7c0d6aa472445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48102-053-05481020053051 KIT in 1 CARTON (48102-053-05) * 6.25 mL in 1 BOTTLE (48102-054-05) * 5 mL in 1 BOTTLE (48102-055-05) 1 kit2022-06-010000-00-00NoNoCurrent
48102-054-05481020054056.25 mL in 1 BOTTLE6.25 mlHistorical