Home NDC 17856-0705-1 Famciclovir
Product NDC 17856-0705
Requested package NDC 17856-0705-1
11-digit product format 178560705
Labeler code 17856
Product ID 17856-0705_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 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 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 · 15 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 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 17856-0705-1 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 17856-0705 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 17856-0705-1 17856070501 30 TABLET, FILM COATED in 1 BOTTLE (17856-0705-1) 2014-09-10 0000-00-00 No No Current