Ribavirin

Product NDC: 65862-290
Requested package NDC: 65862-290-39
11-digit product format: 658620290
Labeler code: 65862
Product ID: 65862-290_229cfa05-05e1-493e-87ba-0511fed12e66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ribavirin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA079117
Marketing category: ANDA
Marketing start: 2009-09-17
Substance: RIBAVIRIN
Active strength: 200 mg/1
Pharmacologic classes: Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-290	65862-290-39	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 20 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`

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
A079117-001	RIBAVIRIN	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A079117-001	AB

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	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB	RS	2009-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079117-001	RIBAVIRIN	200MG	CAPSULE / ORAL	AB		2009-09-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079117-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079117-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079117-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079117-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079117-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079117-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079117-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079117-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079117-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079117-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079117-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079117-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079117-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079117-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079117-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079117-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079117-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079117-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079117-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079117-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079117-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079117-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079117-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079117-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079117-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079117-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079117-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079117-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079117-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079117-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079117-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079117-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079117-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079117-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079117-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079117-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079117-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079117-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079117-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079117-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIBAVIRIN	200 mg/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
312817	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
35f99f76-f2ef-4a81-91ff-285419664be3	Available on FDA.report

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
65862-290-05	Ribavirin	500 in 1 BOTTLE	CAPSULE	500	21
65862-290-18	Ribavirin	180 in 1 BOTTLE	CAPSULE	180	21
65862-290-42	Ribavirin	42 in 1 BOTTLE	CAPSULE	42	21
65862-290-56	Ribavirin	56 in 1 BOTTLE	CAPSULE	56	21
65862-290-70	Ribavirin	70 in 1 BOTTLE	CAPSULE	70	21
65862-290-84	Ribavirin	84 in 1 BOTTLE	CAPSULE	84	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-290-18	EA - Each	65862-290	a3283946-4f06-45c2-89ed-9ee5e6cf6758	1	2012-07-24
65862-290-42	EA - Each	65862-290	091bd220-d01a-4395-8364-db727feb677f	1	2012-07-24
65862-290-56	EA - Each	65862-290	a302d675-06ee-470c-876c-87f2da40cd90	1	2012-07-24
65862-290-70	EA - Each	65862-290	628097c6-de30-45dc-8b3c-e8aeb2053c32	1	2012-07-24
65862-290-84	EA - Each	65862-290	acb4a3af-8fcc-4506-9e34-fac67fb0a0f3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIBAVIRIN	ACTIVE INGREDIENT	49717AWG6K	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
RIBAVIRIN	ACTIVE MOIETY	49717AWG6K	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-290	RIBAVIRIN CAPSULE [AUROBINDO PHARMA LIMITED]	21	Current NDC, Legacy NDC, 6 package rows	20240207_35f99f76-f2ef-4a81-91ff-285419664be3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ribavirin	RIBAVIRIN	Aurobindo Pharma Limited	35f99f76-f2ef-4a81-91ff-285419664be3	2024-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079117 application number: ANDA079117 ndc (product): 65862-290

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
312817	ribavirin 200 MG Oral Capsule	PSN	35f99f76-f2ef-4a81-91ff-285419664be3	21
312817	ribavirin 200 MG Oral Capsule	SCD	35f99f76-f2ef-4a81-91ff-285419664be3	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-290-39	65862029039	3000 CAPSULE in 1 BAG (65862-290-39)	3000 capsule	17-SEP-09	Current