Home NDC 60505-3246 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 RLD / RS 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 · 126 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091480-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-07-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091480-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091480-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-07-22 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
DailyMed RxNorm Mappings# 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