Ribavirin

Product NDC: 68382-046
11-digit product format: 683820046
Labeler code: 68382
Product ID: 68382-046_731a7612-d6ab-4a9c-9347-d3e16fcfbefb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ribavirin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA077094
Marketing category: ANDA
Marketing start: 2005-12-05
Marketing end: 0000-00-00
Substance: RIBAVIRIN
Active strength: 200 mg/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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-046		D	Discontinued by firm	2026-08-07
excluded package	package	68382-046	68382-046-03	D	Discontinued by firm	2026-08-07
excluded package	package	68382-046	68382-046-10	D	Discontinued by firm	2026-08-07
excluded package	package	68382-046	68382-046-28	D	Discontinued by firm	2026-08-07
excluded package	package	68382-046	68382-046-77	D	Discontinued by firm	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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-046-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-046-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-046-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-046-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-046-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-046-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-046-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-046-77	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077094-001	RIBAVIRIN	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05
A077094-002	RIBAVIRIN	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16
A077094-003	RIBAVIRIN	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16
A077094-004	RIBAVIRIN	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077094-001	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077094-001	RIBAVIRIN	200MG	TABLET / ORAL	AB	2005-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077094-002	RIBAVIRIN	400MG	TABLET / ORAL		2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077094-003	RIBAVIRIN	600MG	TABLET / ORAL		2007-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077094-004	RIBAVIRIN	500MG	TABLET / ORAL		2008-04-18	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 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	A077094-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077094-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077094-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077094-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077094-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077094-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077094-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077094-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077094-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077094-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077094-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077094-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077094-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077094-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077094-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077094-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077094-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077094-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077094-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077094-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077094-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077094-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077094-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077094-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077094-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077094-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077094-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077094-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077094-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077094-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077094-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077094-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077094-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077094-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077094-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077094-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077094-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077094-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077094-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077094-001	AB	1	`6a51e52b5d6a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-046-03	EA - Each	68382-046	ab0f4ef8-1a8d-42d6-a8f3-30c30f05fa5a	1	2012-07-24
68382-046-10	EA - Each	68382-046	626f218c-160a-4d74-b82b-42db11109f76	1	2012-07-24
68382-046-28	EA - Each	68382-046	be9751f2-f4b1-46b8-be56-18e9a28cbc73	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RIBAVIRIN	ACTIVE INGREDIENT	49717AWG6K	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
RIBAVIRIN	ACTIVE MOIETY	49717AWG6K	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RIBAVIRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	14

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-046-03	68382004603	168 TABLET, FILM COATED in 1 BOTTLE (68382-046-03)		2005-12-05	0000-00-00	No	No	Current
68382-046-10	68382004610	1000 TABLET, FILM COATED in 1 BOTTLE (68382-046-10)		2005-12-05	0000-00-00	No	No	Current
68382-046-28	68382004628	180 TABLET, FILM COATED in 1 BOTTLE (68382-046-28)		2005-12-05	0000-00-00	No	No	Current
68382-046-77	68382004677	100 BLISTER PACK in 1 CARTON (68382-046-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-046-30)	100 blister pack	2005-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ribavirin	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-11-10	HUMAN PRESCRIPTION DRUG LABEL	19