RIBAVIRIN

Product NDC
68475-003
11-digit product format
684750003
Labeler code
68475
Product ID
68475-003_76819c30-2ece-43cf-a329-6bc3720ac870
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ribavirin
Dosage form
POWDER, FOR SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Navinta LLC
Application
ANDA207366
Marketing category
ANDA
Marketing start
2020-04-21
Substance
RIBAVIRIN
Active strength
6 g/1
Pharmacologic classes
Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIBAVIRIN6 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii49717AWG6K
Rxcui312818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69d6a460-3e15-2628-a0df-cebee0ce913fProduct name220161206
96c088f7-fe95-75d0-c542-fbc93a6056a0Product name220150305
c551530a-adb3-42db-bf59-f11bd7d25fbfProduct name120150305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68475-003-04RIBAVIRIN4 in 1 CARTONPOWDER, FOR SOLUTION42
68475-003-04RIBAVIRIN1 in 1 VIALPOWDER, FOR SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68475-003RIBAVIRIN POWDER, FOR SOLUTION [NAVINTA LLC]2Current NDC, Legacy NDC, 2 package rows20221217_39723ea2-780c-4266-954a-869723b144c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312818ribavirin 6 GM Inhalation SolutionPSN39723ea2-780c-4266-954a-869723b144c42
312818ribavirin 20 MG/ML Inhalation SolutionSCD39723ea2-780c-4266-954a-869723b144c42
312818ribavirin 6 GM Inhalation SolutionSY39723ea2-780c-4266-954a-869723b144c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68475-003-04684750003044 VIAL in 1 CARTON (68475-003-04) / 1 POWDER, FOR SOLUTION in 1 VIAL4 vial2020-04-210000-00-00NoNoCurrent