Home NDC 68475-003 RIBAVIRIN
Product NDC 68475-003
11-digit product format 684750003
Labeler code 68475
Product ID 68475-003_76819c30-2ece-43cf-a329-6bc3720ac870
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ribavirin
Dosage form POWDER, FOR SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Navinta LLC
Application ANDA207366
Marketing category ANDA
Marketing start 2020-04-21
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207366-001 RIBAVIRIN RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION 2016-10-06
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 2 · 41 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 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION RS 2016-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION RS 2016-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207366-001 RIBAVIRIN 6GM/VIAL FOR SOLUTION / INHALATION AN 2016-10-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base RIBAVIRIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIBAVIRIN 6 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 49717AWG6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312818 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68475-003-04 RIBAVIRIN 4 in 1 CARTON POWDER, FOR SOLUTION 4 2 68475-003-04 RIBAVIRIN 1 in 1 VIAL POWDER, FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68475-003 RIBAVIRIN POWDER, FOR SOLUTION [NAVINTA LLC] 2 Current NDC, Legacy NDC, 2 package rows 20221217_39723ea2-780c-4266-954a-869723b144c4.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68475-003-04 68475000304 4 VIAL in 1 CARTON (68475-003-04) / 1 POWDER, FOR SOLUTION in 1 VIAL 4 vial 2020-04-21 0000-00-00 No No Current