Home NDC 0093-8119-99 Famciclovir
Product NDC 0093-8119
Requested package NDC 0093-8119-99
11-digit product format 000938119
Labeler code 0093
Product ID 0093-8119_ce3075f6-1bcc-4cfa-a996-555cb87529ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
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 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 · 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 A077487-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2007-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077487-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2007-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077487-003 FAMCICLOVIR 500MG TABLET / ORAL AB RS 2007-08-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 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 0093-8119-56 Famciclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMCICLOVIR ACTIVE INGREDIENT QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 PENCICLOVIR ACTIVE MOIETY 359HUE8FJC FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 HYPROMELLOSE 2910 (50 MPA.S) INACTIVE INGREDIENT 1IVH67816N FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 9 FAMCICLOVIR ACTIVE INGREDIENT QIC03ANI02 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 Penciclovir ACTIVE MOIETY 359HUE8FJC FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [AVKARE, INC.] 6 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 FAMCICLOVIR ACTIVE INGREDIENT QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 FAMCICLOVIR ACTIVE MOIETY QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-8119 FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20230807_3f02042f-8f51-4ccf-b608-5dcd75d100fb.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 Status 0093-8119-99 00093811999 25467 TABLET, FILM COATED in 1 PAIL (0093-8119-99) 05-MAY-23 Current