Home NDC 31722-706 Famciclovir
Product NDC 31722-706
11-digit product format 317220706
Labeler code 31722
Product ID 31722-706_2b438049-f70c-5388-e063-6394a90af892
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famciclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA202438
Marketing category ANDA
Marketing start 2014-09-10
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 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 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 31722-706-01 2021-02-19 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-05 2021-02-19 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-10 2021-02-19 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-30 2021-02-19 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-60 2021-02-19 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-01 2021-01-29 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-05 2021-01-29 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-10 2021-01-29 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-30 2021-01-29 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994 31722-706-60 2021-01-29 These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablet, for oral use Initial U.S. Approval: 1994
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-706-01 Famciclovir 100 in 1 BOTTLE TABLET, FILM COATED 100 7 31722-706-05 Famciclovir 500 in 1 BOTTLE TABLET, FILM COATED 500 7 31722-706-10 Famciclovir 1000 in 1 BOTTLE TABLET, FILM COATED 1000 7 31722-706-30 Famciclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 7 31722-706-60 Famciclovir 60 in 1 BOTTLE TABLET, FILM COATED 60 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMCICLOVIR ACTIVE INGREDIENT QIC03ANI02 FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 PENCICLOVIR ACTIVE MOIETY 359HUE8FJC FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMCICLOVIR TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-706 FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 5 package rows 20250110_08c58224-5920-4853-8c59-ec5fbb66c2f6.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 31722-706-01 31722070601 100 TABLET, FILM COATED in 1 BOTTLE (31722-706-01) 2014-09-10 0000-00-00 No No Current 31722-706-05 31722070605 500 TABLET, FILM COATED in 1 BOTTLE (31722-706-05) 2014-09-10 0000-00-00 No No Current 31722-706-10 31722070610 1000 TABLET, FILM COATED in 1 BOTTLE (31722-706-10) 2014-09-10 0000-00-00 No No Current 31722-706-30 31722070630 30 TABLET, FILM COATED in 1 BOTTLE (31722-706-30) 2014-09-10 0000-00-00 No No Current 31722-706-60 31722070660 60 TABLET, FILM COATED in 1 BOTTLE (31722-706-60) 2014-09-10 0000-00-00 No No Current