Home NDC 42291-415-30 Famciclovir
Product NDC 42291-415
Requested package NDC 42291-415-30
11-digit product format 422910415
Labeler code 42291
Product ID 42291-415_485cfe40-2ff0-e83f-e063-6394a90a221c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA077487
Marketing category ANDA
Marketing start 2021-05-19
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A077487-001 FAMCICLOVIR FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 A077487-002 FAMCICLOVIR FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 A077487-003 FAMCICLOVIR FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 123 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 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Famciclovir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMCICLOVIR 250 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-415-30 Famciclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-415 FAMCICLOVIR TABLET, FILM COATED [AVKARE] 3 Current NDC, Legacy NDC, 1 package rows 20240110_c2b21ad5-fa83-1fb6-e053-2a95a90a3d0f.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 · 3 matching rows.
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 42291-415-30 42291041530 30 TABLET, FILM COATED in 1 BOTTLE (42291-415-30) 2021-05-19 0000-00-00 No No Current