Ribavirin

Product NDC
63629-2149
11-digit product format
636292149
Labeler code
63629
Product ID
63629-2149_dea68b80-8701-42ad-8cbd-024d96499b3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ribavirin
Dosage form
POWDER, FOR SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Bryant Ranch Prepack
Application
NDA018859
Marketing category
NDA
Marketing start
2020-04-15
Marketing end
0000-00-00
Substance
RIBAVIRIN
Active strength
6 g/1
Pharmacologic classes
Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-2149DDiscontinued by firm2026-08-07
excluded packagepackage63629-214963629-2149-1DDiscontinued by firm2026-08-07

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018859-001VIRAZOLERIBAVIRIN6GM/VIALFOR SOLUTION / INHALATIONRLD1985-12-31

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONRLD1985-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONRLD1985-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-313f01610625f2…
2019-09-15 20:21 UTC2019-09N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018859-001VIRAZOLE6GM/VIALFOR SOLUTION / INHALATIONANRLD, RS1985-12-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N018859-001AN16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018859-001AN1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018859-001AN1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018859-001AN103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018859-001AN12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018859-001AN15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018859-001AN1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018859-001AN1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018859-001AN179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018859-001AN1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018859-001AN11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018859-001AN18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018859-001AN15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018859-001AN15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018859-001AN14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018859-001AN174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018859-001AN1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018859-001AN1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018859-001AN187673890dc5c…
2021-03-12 10:30 UTC2021-03N018859-001AN15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018859-001AN18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018859-001AN1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018859-001AN13f01610625f2…
2019-09-15 20:21 UTC2019-09N018859-001AN1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018859-001AN1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018859-001AN16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018859-001AN11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018859-001AN1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018859-001AN1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018859-001AN19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018859-001AN1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018859-001AN13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018859-001AN1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018859-001AN13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018859-001AN13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018859-001AN1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018859-001AN1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018859-001AN1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2149-1EA - Each63629-21496043fa7c-b7c7-45d4-9b72-4b503ed8311412021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2149RIBAVIRIN POWDER, FOR SOLUTION [BRYANT RANCH PREPACK]103Legacy NDC20240112_1ca2a558-2989-4e16-94de-ebe0dd801267.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RibavirinRIBAVIRINBryant Ranch Prepack3631ee95-692a-4426-8edf-62c27f7c32cb2024-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018859
application number: NDA018859
RibavirinRIBAVIRINOceanside Pharmaceuticalsd74aa4f3-0b7d-480d-b5bf-41ddf808b2602019-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018859
application number: NDA018859

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2149-1636292149011 VIAL, GLASS in 1 CARTON (63629-2149-1) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS2021-02-150000-00-00NoNoCurrent