Home NDC 66435-103 RIBASPHERE
Product NDC 66435-103
11-digit product format 664350103
Labeler code 66435
Product ID 66435-103_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ribavirin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kadmon Pharmaceuticals, LLC
Application ANDA077456
Marketing category ANDA
Marketing start 2005-12-05
Marketing end 0000-00-00
Substance RIBAVIRIN
Active strength 400 mg/1
Pharmacologic classes Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077456-001 RIBAVIRIN RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 A077456-002 RIBAVIRIN RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 A077456-003 RIBAVIRIN RIBAVIRIN 600MG TABLET / ORAL 2005-12-05
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077456-002 RIBAVIRIN 400MG TABLET / ORAL 2005-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077456-003 RIBAVIRIN 600MG TABLET / ORAL 2005-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077456-001 RIBAVIRIN 200MG TABLET / ORAL 2005-12-05 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIBAVIRIN ACTIVE INGREDIENT 49717AWG6K RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 RIBAVIRIN ACTIVE MOIETY 49717AWG6K RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8 WATER INACTIVE INGREDIENT 059QF0KO0R RIBASPHERE RIBAPAK (RIBAVIRIN) KIT RIBASPHERE RIBAPAK (RIBAVIRIN) TABLET RIBASPHERE (RIBAVIRIN) TABLET, FILM COATED [KADMON PHARMACEUTICALS, LLC] 8