Virazole

Product NDC: 0187-0007
11-digit product format: 001870007
Labeler code: 0187
Product ID: 0187-0007_a2282c58-67c0-48ac-ae4f-f05e98d6f3c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ribavirin
Dosage form: POWDER, FOR SOLUTION
Route: RESPIRATORY (INHALATION)
Labeler: Bausch Health US, LLC
Application: NDA018859
Marketing category: NDA
Marketing start: 1986-01-01
Marketing end: 2026-05-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0187-0007		D	Discontinued by firm	2026-08-17
excluded package	package	0187-0007	0187-0007-01	D	Discontinued by firm	2026-08-17
excluded package	package	0187-0007	0187-0007-14	D	Discontinued by firm	2026-08-17

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-0007	0187-0007-14	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-0007	0187-0007-14	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	N018859-001	VIRAZOLE	6GM/VIAL	FOR SOLUTION / INHALATION		RLD	1985-12-31	`caaa826d4ba7…`
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…`

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	SPL version
0187-0007-01	Virazole	1 in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1	12
0187-0007-01	Virazole	1 in 1 CARTON	POWDER, FOR SOLUTION	1	12
0187-0007-14	Virazole	4 in 1 CARTON	POWDER, FOR SOLUTION	4	12
0187-0007-14	Virazole	1 in 1 VIAL, GLASS	POWDER, FOR SOLUTION	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0007-14	EA - Each	0187-0007	590b0b6f-87b8-471d-987a-505caf1d3e5f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Ribavirin	ACTIVE INGREDIENT	49717AWG6K	VIRAZOLE (RIBAVIRIN) POWDER, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
Ribavirin	ACTIVE MOIETY	49717AWG6K	VIRAZOLE (RIBAVIRIN) POWDER, FOR SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-0007	VIRAZOLE (RIBAVIRIN) POWDER, FOR SOLUTION [BAUSCH HEALTH US, LLC]	10	Current NDC, Legacy NDC, 4 package rows	20230208_adf16e64-345f-469a-b987-3fbdd17e0ac2.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-0007-01	00187000701	1 VIAL, GLASS in 1 CARTON (0187-0007-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS	2019-08-27	2026-05-31	No	No	Current
0187-0007-14	00187000714	4 VIAL, GLASS in 1 CARTON (0187-0007-14) > 1 POWDER, FOR SOLUTION in 1 VIAL, GLASS	1986-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VIRAZOLE® (Ribavirin for Inhalation Solution, USP)	Bausch Health US, LLC \| Hospira, Inc.	2025-08-14	HUMAN PRESCRIPTION DRUG LABEL	12