Ribavirin

Product NDC: 42494-423
11-digit product format: 424940423
Labeler code: 42494
Product ID: 42494-423_4f6faa39-5ffa-18d6-e063-6394a90a8e07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ribavirin
Dosage form: POWDER, FOR SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Cameron Pharmaceuticals
Application: NDA018859
Marketing category: NDA
Marketing start: 2020-04-15
Marketing end: 2026-06-30
Substance: RIBAVIRIN
Active strength: 6 g/1
Pharmacologic classes: Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42494-423		D	Discontinued by firm		2026-08-07
excluded package	package	42494-423	42494-423-01	D	Discontinued by firm		2026-08-07

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018859-001	VIRAZOLE	RIBAVIRIN	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31

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
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	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION	AN	RLD, RS	1985-12-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N018859-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018859-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018859-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018859-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018859-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018859-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018859-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018859-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018859-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018859-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018859-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018859-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018859-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018859-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018859-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018859-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018859-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018859-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018859-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018859-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018859-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018859-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018859-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018859-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018859-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018859-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018859-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018859-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018859-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018859-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018859-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018859-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018859-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018859-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018859-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018859-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018859-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018859-001	AN	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
69d6a460-3e15-2628-a0df-cebee0ce913f	Product name	2	20161206
96c088f7-fe95-75d0-c542-fbc93a6056a0	Product name	2	20150305
c551530a-adb3-42db-bf59-f11bd7d25fbf	Product name	1	20150305

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42494-423-01	Ribavirin	1 in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1		3
42494-423-01	Ribavirin	1 in 1 CARTON	POWDER, FOR SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42494-423-01	EA - Each	42494-423	7cc6a99d-2fa4-4b9d-a244-6e8dda666155	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42494-423	RIBAVIRIN POWDER, FOR SOLUTION [CAMERON PHARMACEUTICALS]	1	Current NDC, Legacy NDC, 2 package rows	20200502_7ea8dafa-d3d8-493e-a0db-e783d92fb13f.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ribavirin	RIBAVIRIN	Bryant Ranch Prepack	3631ee95-692a-4426-8edf-62c27f7c32cb	2024-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018859 application number: NDA018859
Ribavirin	RIBAVIRIN	Oceanside Pharmaceuticals	d74aa4f3-0b7d-480d-b5bf-41ddf808b260	2019-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018859 application number: NDA018859

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
49717AWG6K	RIBAVIRIN	36791-04-5	RIBAVIRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312818	ribavirin 6 GM Inhalation Solution	PSN	3631ee95-692a-4426-8edf-62c27f7c32cb	100
312818	ribavirin 20 MG/ML Inhalation Solution	SCD	3631ee95-692a-4426-8edf-62c27f7c32cb	100
312818	ribavirin 6 GM Inhalation Solution	SY	3631ee95-692a-4426-8edf-62c27f7c32cb	100
312818	ribavirin 6 GM Inhalation Solution	PSN	7ea8dafa-d3d8-493e-a0db-e783d92fb13f	3
312818	ribavirin 20 MG/ML Inhalation Solution	SCD	7ea8dafa-d3d8-493e-a0db-e783d92fb13f	3
312818	ribavirin 6 GM Inhalation Solution	SY	7ea8dafa-d3d8-493e-a0db-e783d92fb13f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42494-423-01	42494042301	1 VIAL, GLASS in 1 CARTON (42494-423-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS	2020-04-15	2026-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ribavirin for Inhalation Solution, USP	Cameron Pharmaceuticals \| Hospira, Inc.	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	3
Ribavirin for Inhalation Solution, USP	Bryant Ranch Prepack	2024-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
Ribavirin for Inhalation Solution, USP	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	103