Famciclovir

Product NDC: 73190-091
11-digit product format: 731900091
Labeler code: 73190
Product ID: 73190-091_5723f51d-d8b3-2a59-e063-6394a90a9328
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famciclovir
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA202438
Marketing category: ANDA
Marketing start: 2026-07-21
Substance: FAMCICLOVIR
Active strength: 125 mg/1
Pharmacologic classes: DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202438-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10
A202438-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10
A202438-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202438-001	AB
A202438-002	AB
A202438-003	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 4 · 129 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
2026-09-14 22:38:34	2026-08	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2014-09-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202438-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202438-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202438-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202438-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202438-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202438-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202438-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202438-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202438-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202438-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202438-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202438-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202438-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202438-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202438-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202438-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202438-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Famciclovir
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMCICLOVIR	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QIC03ANI02	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198382	Internal RxNorm lookup
199192	Internal RxNorm lookup
199193	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
5723f50e-b0fa-65f0-e063-6294a90a350f	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famciclovir	FAMCICLOVIR	AvKARE	5723f50e-b0fa-65f0-e063-6294a90a350f	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438 ndc (product): 73190-091
Famciclovir	FAMCICLOVIR	Bryant Ranch Prepack	2c579bc7-8130-4935-a999-62b4b1c20706	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438
Famciclovir	FAMCICLOVIR	Camber Pharmaceuticals, Inc.	08c58224-5920-4853-8c59-ec5fbb66c2f6	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438
Famciclovir	FAMCICLOVIR	Proficient Rx LP	29b7ea8b-b976-45cb-9006-a27ba797b0fd	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202438 application number: ANDA202438

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QIC03ANI02	FAMCICLOVIR	104227-87-4	FAMCICLOVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73190-091-30	73190009130	30 TABLET, FILM COATED in 1 BOTTLE (73190-091-30)	2026-07-21	No	No	Current