FAMCICLOVIR

Product NDC: 60505-3246
11-digit product format: 605053246
Labeler code: 60505
Product ID: 60505-3246_e3d7739d-57fe-7036-bb4e-065f64e48912
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FAMCICLOVIR
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA091480
Marketing category: ANDA
Marketing start: 2011-12-20
Marketing end: 0000-00-00
Substance: FAMCICLOVIR
Active strength: 250 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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-3246		D	Discontinued by firm		2026-10-05
excluded package	package	60505-3246	60505-3246-3	D	Discontinued by firm		2026-10-05

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	Approval date
A091480-001	FAMCICLOVIR	FAMCICLOVIR	125MG	TABLET / ORAL	2011-07-22
A091480-002	FAMCICLOVIR	FAMCICLOVIR	250MG	TABLET / ORAL	2011-07-22
A091480-003	FAMCICLOVIR	FAMCICLOVIR	500MG	TABLET / ORAL	2011-07-22

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	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL		2011-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL		2011-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL		2011-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL		2011-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL		2011-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL		2011-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091480-002	FAMCICLOVIR	250MG	TABLET / ORAL	AB	2011-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091480-003	FAMCICLOVIR	500MG	TABLET / ORAL	AB	2011-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091480-001	FAMCICLOVIR	125MG	TABLET / ORAL	AB	2011-07-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A091480-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091480-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091480-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091480-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091480-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091480-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091480-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091480-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091480-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091480-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091480-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091480-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091480-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091480-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091480-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091480-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091480-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091480-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091480-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091480-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091480-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091480-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091480-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091480-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091480-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091480-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091480-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091480-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091480-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091480-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091480-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091480-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091480-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091480-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091480-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091480-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091480-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091480-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091480-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091480-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1005b6ff-d0c1-48ab-8c99-f6ab62104661	Product name	2	20250401
39b4c6c3-4107-094f-96fa-0d1c48033493	Product name	2	20150326

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-3246-3	FAMCICLOVIR	30 in 1 BOTTLE	TABLET, FILM COATED	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3246-3	EA - Each	60505-3246	e844411f-dc60-4302-857b-44f76e65c295	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMCICLOVIR	ACTIVE INGREDIENT	QIC03ANI02	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
penciclovir	ACTIVE MOIETY	359HUE8FJC	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	8
FAMCICLOVIR	ACTIVE INGREDIENT	QIC03ANI02	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FAMCICLOVIR	ACTIVE MOIETY	QIC03ANI02	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FAMCICLOVIR TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3246	FAMCICLOVIR TABLET, FILM COATED [APOTEX CORP.]	18	Legacy NDC, 1 package rows	20240423_a5c46194-3692-cd26-0d85-6371974ccc44.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199192	famciclovir 125 MG Oral Tablet	PSN	a5c46194-3692-cd26-0d85-6371974ccc44	18
199193	famciclovir 250 MG Oral Tablet	PSN	a5c46194-3692-cd26-0d85-6371974ccc44	18
198382	famciclovir 500 MG Oral Tablet	PSN	a5c46194-3692-cd26-0d85-6371974ccc44	18
199192	famciclovir 125 MG Oral Tablet	SCD	a5c46194-3692-cd26-0d85-6371974ccc44	18
199193	famciclovir 250 MG Oral Tablet	SCD	a5c46194-3692-cd26-0d85-6371974ccc44	18
198382	famciclovir 500 MG Oral Tablet	SCD	a5c46194-3692-cd26-0d85-6371974ccc44	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3246-3	60505324603	30 TABLET, FILM COATED in 1 BOTTLE (60505-3246-3)	2011-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FAMCICLOVIR	Apotex Corp. \| Apotex Inc.	2024-04-22	HUMAN PRESCRIPTION DRUG LABEL	18
FAMCICLOVIR	Golden State Medical Supply, Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	5