Home NDC 63629-7890 Famciclovir
Product NDC 63629-7890
11-digit product format 636297890
Labeler code 63629
Product ID 63629-7890_65eceb53-43c8-44c5-95f0-62304e8d75c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202438
Marketing category ANDA
Marketing start 2014-09-10
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 · 26 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 2025-04-01 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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 63629-7890-1 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.
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-7890-1 Famciclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7890 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [BRYANT RANCH PREPACK] 3 Current NDC, Legacy NDC, 1 package rows 20250327_2c579bc7-8130-4935-a999-62b4b1c20706.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 63629-7890-1 63629789001 30 TABLET, FILM COATED in 1 BOTTLE (63629-7890-1) 2019-01-11 0000-00-00 No No Current