Home NDC 55289-168-03 Famciclovir
Product NDC 55289-168
Requested package NDC 55289-168-03
11-digit product format 552890168
Labeler code 55289
Product ID 55289-168_4199c092-c45c-3922-e063-6294a90aadb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA077487
Marketing category ANDA
Marketing start 2007-09-05
Substance FAMCICLOVIR
Active strength 500 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 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMCICLOVIR 500 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198382 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 55289-168-03 Famciclovir 3 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 3 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMCICLOVIR ACTIVE INGREDIENT QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 FAMCICLOVIR ACTIVE MOIETY QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-168 FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20240312_2c44b8d2-3b70-4e8b-af03-2e917178f761.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 55289-168-03 55289016803 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03) 2011-04-14 0000-00-00 No No Current