Ribavirin

Product NDC
53808-0782
11-digit product format
538080782
Labeler code
53808
Product ID
53808-0782_e6e8d35d-d5c7-4149-9167-b7e2d0588bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIBAVIRIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA077224
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
RIBAVIRIN
Active strength
200 mg/1
Pharmacologic classes
Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
69d6a460-3e15-2628-a0df-cebee0ce913fProduct name220161206
96c088f7-fe95-75d0-c542-fbc93a6056a0Product name220150305
c551530a-adb3-42db-bf59-f11bd7d25fbfProduct name120150305

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0782-12019-10-21C16284748780-1956f9ecf-bc91-621f-e053-dbdaa90a74adRIBAVIRIN TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0782-1Ribavirin30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIBAVIRINACTIVE INGREDIENT49717AWG6KRIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
RIBAVIRINACTIVE MOIETY49717AWG6KRIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WORIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ARIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ERIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1URIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0782RIBAVIRIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100804_14d74b63-34ca-4897-bfdd-3e3952ab6088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248109ribavirin 200 MG Oral TabletPSN14d74b63-34ca-4897-bfdd-3e3952ab60881
248109ribavirin 200 MG Oral TabletSCD14d74b63-34ca-4897-bfdd-3e3952ab60881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0782-15380807820130 in 1 BLISTER PACKHistorical