Home NDC 65862-465-49 Famciclovir
Product NDC 65862-465
Requested package NDC 65862-465-49
11-digit product format 658620465
Labeler code 65862
Product ID 65862-465_c372e46a-af0b-43c2-8f33-d20e4c6e27d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA091114
Marketing category ANDA
Marketing start 2011-03-21
Substance FAMCICLOVIR
Active strength 125 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 · 21 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…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 A091114-001 FAMCICLOVIR FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 A091114-002 FAMCICLOVIR FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 A091114-003 FAMCICLOVIR FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21
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 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091114-002 FAMCICLOVIR 250MG TABLET / ORAL AB 2011-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091114-003 FAMCICLOVIR 500MG TABLET / ORAL AB 2011-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091114-001 FAMCICLOVIR 125MG TABLET / ORAL AB 2011-03-21 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 125 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 65862-465-30 Famciclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 19 65862-465-50 Famciclovir 5 in 1 CARTON TABLET, FILM COATED 5 19 65862-465-50 Famciclovir 10 in 1 BLISTER PACK TABLET, FILM COATED 10 19 65862-465-99 Famciclovir 1000 in 1 BOTTLE TABLET, FILM COATED 1000 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMCICLOVIR ACTIVE INGREDIENT QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 PENCICLOVIR ACTIVE MOIETY 359HUE8FJC FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-465 FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 19 Current NDC, Legacy NDC, 4 package rows 20240618_fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 65862-465-49 65862046549 4000 TABLET, FILM COATED in 1 BAG (65862-465-49) 21-MAR-11 Current