FDA.reportPublic FDA data

Betadine

Product NDC
42254-006
11-digit product format
422540006
Labeler code
42254
Product ID
42254-006_72287bb4-3f70-4e12-aaf3-cfff48e044f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
povidone-iodine
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
NDA018634
Marketing category
NDA
Marketing start
2000-04-01
Marketing end
0000-00-00
Substance
POVIDONE-IODINE
Active strength
5 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-006-302019-09-24C16284748780-19350213a-3ccb-c013-e053-90daa90a1393Betadine® 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-006-30Betadine30 mL in 1 BOTTLESOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-006-30ML - Milliliter42254-00603bbbee9-f195-42e3-b4e5-37c79140e46b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MBETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
IODINEACTIVE MOIETY9679TC07X4BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TBETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-006BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20111208_72287bb4-3f70-4e12-aaf3-cfff48e044f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1149663Betadine 5 % Ophthalmic SolutionPSN72287bb4-3f70-4e12-aaf3-cfff48e044f81
312570povidone-iodine 5 % Ophthalmic SolutionPSN72287bb4-3f70-4e12-aaf3-cfff48e044f81
1149663povidone-iodine 50 MG/ML Ophthalmic Solution [Betadine]SBD72287bb4-3f70-4e12-aaf3-cfff48e044f81
312570povidone-iodine 50 MG/ML Ophthalmic SolutionSCD72287bb4-3f70-4e12-aaf3-cfff48e044f81
1149663Betadine 50 MG/ML Ophthalmic SolutionSY72287bb4-3f70-4e12-aaf3-cfff48e044f81
1149663Betadine Ophthalmic Prep 5 % Ophthalmic SolutionSY72287bb4-3f70-4e12-aaf3-cfff48e044f81
312570povidone-iodine 5 % Ophthalmic SolutionSY72287bb4-3f70-4e12-aaf3-cfff48e044f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-006-304225400063030 mL in 1 BOTTLE30 mlHistorical