Ribavirin

Product NDC
72162-1331
11-digit product format
721621331
Labeler code
72162
Product ID
72162-1331_7174eb35-aaf9-4f21-a04e-178d6d4339f6
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
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-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…

Additional Listing Data#

Finished product
Yes
Brand name base
Ribavirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIBAVIRIN6 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
49717AWG6KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312818Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3631ee95-692a-4426-8edf-62c27f7c32cbAvailable on FDA.report

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
72162-1331-2Ribavirin1 in 1 VIAL, GLASSPOWDER, FOR SOLUTION1100
72162-1331-2Ribavirin1 in 1 CARTONPOWDER, FOR SOLUTION1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1331-2EA - Each72162-1331888952c6-5e15-4df7-a835-c70b48b39f2712024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1331RIBAVIRIN POWDER, FOR SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240210_3631ee95-692a-4426-8edf-62c27f7c32cb.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
ndc (product): 72162-1331
RibavirinRIBAVIRINOceanside Pharmaceuticalsd74aa4f3-0b7d-480d-b5bf-41ddf808b2602019-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018859
application number: NDA018859

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312818ribavirin 6 GM Inhalation SolutionPSN3631ee95-692a-4426-8edf-62c27f7c32cb100
312818ribavirin 20 MG/ML Inhalation SolutionSCD3631ee95-692a-4426-8edf-62c27f7c32cb100
312818ribavirin 6 GM Inhalation SolutionSY3631ee95-692a-4426-8edf-62c27f7c32cb100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1331-2721621331021 VIAL, GLASS in 1 CARTON (72162-1331-2) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS2024-02-09NoNoCurrent