IOPIDINE

Product NDC
0065-0660
11-digit product format
000650660
Labeler code
0065
Product ID
0065-0660_1476ec41-31c3-4848-9bfd-8899fa302fc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apraclonidine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA019779
Marketing category
NDA
Marketing start
1988-05-15
Marketing end
0000-00-00
Substance
APRACLONIDINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
02c8f418-c0c9-b236-9f18-ee3885c38acdProduct name120140508
ba85cd0d-986e-2249-069d-4a15a4d0199fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0065-0660-102023-01-30C16284748780-1f386c649-e762-0266-e053-dadaa90a7c1aIOPIDINE* 1% (apraclonidine hydrochloride ophthalmic solution) 1% as base Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0660-10IOPIDINE12 in 1 CARTONSOLUTION/ DROPS1211
0065-0660-10IOPIDINE2 in 1 POUCHSOLUTION/ DROPS211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0660-10EA - Each0065-0660de043467-9442-4c19-bfb3-3f1dc419600112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0660IOPIDINE (APRACLONIDINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]11Legacy NDC, 2 package rows20211008_2a6c44a6-e415-467f-bf3b-3e7f2c7dc714.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308346apraclonidine HCl 1 % Ophthalmic SolutionPSN2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
211020IOPIDINE 1 % Ophthalmic SolutionPSN2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
211020apraclonidine 10 MG/ML Ophthalmic Solution [Iopidine]SBD2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
308346apraclonidine 10 MG/ML Ophthalmic SolutionSCD2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
308346apraclonidine 1 % Ophthalmic SolutionSY2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
308346apraclonidine 10 MG/ML (apraclonidine hydrochloride 11.5 MG/ML) Ophthalmic SolutionSY2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
211020Iopidine 1 % Ophthalmic SolutionSY2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
211020Iopidine 10 MG/ML (apraclonidine hydrochloride 11.5 MG/ML) Ophthalmic SolutionSY2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411
211020Iopidine 10 MG/ML Ophthalmic SolutionSY2a6c44a6-e415-467f-bf3b-3e7f2c7dc71411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0660-100006506601012 POUCH in 1 CARTON (0065-0660-10) > 2 VIAL, SINGLE-USE in 1 POUCH > .1 mL in 1 VIAL, SINGLE-USE12 pouch1988-05-150000-00-00NoNoCurrent