Ribavirin

Product NDC
65862-207
11-digit product format
658620207
Labeler code
65862
Product ID
65862-207_683ccd3f-445b-4488-b14c-8d5810d8633a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ribavirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079111
Marketing category
ANDA
Marketing start
2009-09-17
Substance
RIBAVIRIN
Active strength
200 mg/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
RIBAVIRIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii49717AWG6K
Rxcui248109

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
65862-207-05Ribavirin500 in 1 BOTTLETABLET, FILM COATED50019
65862-207-68Ribavirin168 in 1 BOTTLETABLET, FILM COATED16819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-207-68EA - Each65862-2070eb4c0ec-0143-4d43-9fa0-6f08d00599b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIBAVIRINACTIVE INGREDIENT49717AWG6KRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
RIBAVIRINACTIVE MOIETY49717AWG6KRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
POVIDONE K30INACTIVE INGREDIENTU725QWY32XRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2RIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12
TRIACETININACTIVE INGREDIENTXHX3C3X673RIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-207RIBAVIRIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 2 package rows20240207_eee304d0-c2ea-44f4-97d9-92a414d31b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248109ribavirin 200 MG Oral TabletPSNeee304d0-c2ea-44f4-97d9-92a414d31b6c19
248109ribavirin 200 MG Oral TabletSCDeee304d0-c2ea-44f4-97d9-92a414d31b6c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-207-0565862020705500 TABLET, FILM COATED in 1 BOTTLE (65862-207-05) 2009-09-170000-00-00NoNoCurrent
65862-207-6865862020768168 TABLET, FILM COATED in 1 BOTTLE (65862-207-68) 2009-09-170000-00-00NoNoCurrent