FDA.reportPublic FDA data

Ribavirin

Product NDC
65862-290
11-digit product format
658620290
Labeler code
65862
Product ID
65862-290_229cfa05-05e1-493e-87ba-0511fed12e66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ribavirin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA079117
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
Rxcui312817

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
65862-290-05Ribavirin500 in 1 BOTTLECAPSULE50021
65862-290-18Ribavirin180 in 1 BOTTLECAPSULE18021
65862-290-42Ribavirin42 in 1 BOTTLECAPSULE4221
65862-290-56Ribavirin56 in 1 BOTTLECAPSULE5621
65862-290-70Ribavirin70 in 1 BOTTLECAPSULE7021
65862-290-84Ribavirin84 in 1 BOTTLECAPSULE8421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-290-18EA - Each65862-290a3283946-4f06-45c2-89ed-9ee5e6cf675812012-07-24
65862-290-42EA - Each65862-290091bd220-d01a-4395-8364-db727feb677f12012-07-24
65862-290-56EA - Each65862-290a302d675-06ee-470c-876c-87f2da40cd9012012-07-24
65862-290-70EA - Each65862-290628097c6-de30-45dc-8b3c-e8aeb2053c3212012-07-24
65862-290-84EA - Each65862-290acb4a3af-8fcc-4506-9e34-fac67fb0a0f312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIBAVIRINACTIVE INGREDIENT49717AWG6KRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
RIBAVIRINACTIVE MOIETY49717AWG6KRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
GELATININACTIVE INGREDIENT2G86QN327LRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-290RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]21Current NDC, Legacy NDC, 6 package rows20240207_35f99f76-f2ef-4a81-91ff-285419664be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312817ribavirin 200 MG Oral CapsulePSN35f99f76-f2ef-4a81-91ff-285419664be321
312817ribavirin 200 MG Oral CapsuleSCD35f99f76-f2ef-4a81-91ff-285419664be321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-290-0565862029005500 CAPSULE in 1 BOTTLE (65862-290-05) 500 capsule2009-09-170000-00-00NoNoCurrent
65862-290-1865862029018180 CAPSULE in 1 BOTTLE (65862-290-18) 180 capsule2009-09-170000-00-00NoNoCurrent
65862-290-426586202904242 CAPSULE in 1 BOTTLE (65862-290-42) 42 capsule2009-09-170000-00-00NoNoCurrent
65862-290-566586202905656 CAPSULE in 1 BOTTLE (65862-290-56) 56 capsule2009-09-170000-00-00NoNoCurrent
65862-290-706586202907070 CAPSULE in 1 BOTTLE (65862-290-70) 70 capsule2009-09-170000-00-00NoNoCurrent
65862-290-846586202908484 CAPSULE in 1 BOTTLE (65862-290-84) 84 capsule2009-09-170000-00-00NoNoCurrent