FDA.reportPublic FDA data

Ribavirin

Product NDC
68682-019
11-digit product format
686820019
Labeler code
68682
Product ID
68682-019_6b3c6edc-c735-46e0-9b31-fac85dda0992
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ribavirin
Dosage form
POWDER, FOR SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Oceanside Pharmaceuticals
Application
NDA018859
Marketing category
NDA
Marketing start
2017-04-14
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
68682-019-01Ribavirin1 in 1 VIAL, GLASSPOWDER, FOR SOLUTION16
68682-019-01Ribavirin1 in 1 CARTONPOWDER, FOR SOLUTION16
68682-019-06Ribavirin1 in 1 VIAL, GLASSPOWDER, FOR SOLUTION16
68682-019-06Ribavirin4 in 1 CARTONPOWDER, FOR SOLUTION46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-019-01EA - Each68682-0196a608df0-1501-461b-bbac-5809b119697b12022-11-07
68682-019-06EA - Each68682-019977c73f5-8b8d-4107-ba54-3fd24721f2cb12017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-019RIBAVIRIN POWDER, FOR SOLUTION [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 4 package rows20230208_d74aa4f3-0b7d-480d-b5bf-41ddf808b260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312818ribavirin 6 GM Inhalation SolutionPSNd74aa4f3-0b7d-480d-b5bf-41ddf808b2606
312818ribavirin 20 MG/ML Inhalation SolutionSCDd74aa4f3-0b7d-480d-b5bf-41ddf808b2606
312818ribavirin 6 GM Inhalation SolutionSYd74aa4f3-0b7d-480d-b5bf-41ddf808b2606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-019-01686820019011 VIAL, GLASS in 1 CARTON (68682-019-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS2019-08-270000-00-00NoNoCurrent
68682-019-06686820019064 VIAL, GLASS in 1 CARTON (68682-019-06) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS2017-04-140000-00-00NoNoCurrent