Home NDC 17856-0708 Famciclovir
Product NDC 17856-0708
11-digit product format 178560708
Labeler code 17856
Product ID 17856-0708_b2225461-d7b7-45ef-a1a5-b3da71890e97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA202438
Marketing category ANDA
Marketing start 2014-09-10
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17856-0708-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17856-0708-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17856-0708-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17856-0708-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-0708-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-0708-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-0708-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-0708-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-0708-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17856-0708-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17856-0708-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17856-0708-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-0708-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-0708-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0708-1 1332a3947898…d4bfe170f9cd…
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 A202438-001 FAMCICLOVIR FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 A202438-002 FAMCICLOVIR FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 A202438-003 FAMCICLOVIR FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10
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 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202438-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2014-09-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202438-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2014-09-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202438-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2014-09-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0708-1 Famciclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0708 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.] 1 Legacy NDC, 1 package rows 20210406_2337e2f6-039b-4f5c-bca4-b0771c4cb632.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 · 4 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 17856-0708-1 17856070801 30 TABLET, FILM COATED in 1 BOTTLE (17856-0708-1) 2014-09-10 0000-00-00 No No Current