Home NDC 42794-003 ADEFOVIR DIPIVOXIL
Product NDC 42794-003
11-digit product format 427940003
Labeler code 42794
Product ID 42794-003_f7ac2b46-04c8-a739-e053-6394a90a7711
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ADEFOVIR DIPIVOXIL
Dosage form TABLET
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA202051
Marketing category ANDA
Marketing start 2013-09-03
Substance ADEFOVIR DIPIVOXIL
Active strength 10 mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202051-001 ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202051-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB RS 2013-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202051-001 ADEFOVIR DIPIVOXIL 10MG TABLET / ORAL AB 2013-08-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ADEFOVIR DIPIVOXIL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADEFOVIR DIPIVOXIL 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U6Q8Z01514 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 881341 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 42794-003-08 ADEFOVIR DIPIVOXIL 30 in 1 BOTTLE TABLET 30 8 42794-003-08 ADEFOVIR DIPIVOXIL 1 in 1 CARTON TABLET 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ADEFOVIR DIPIVOXIL ACTIVE INGREDIENT U6Q8Z01514 ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 ADEFOVIR ACTIVE MOIETY 6GQP90I798 ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-003 ADEFOVIR DIPIVOXIL TABLET [SIGMAPHARM LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20230325_e047f3b2-feae-4c5e-9d07-1fefb4c0ec25.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42794-003-08 42794000308 1 BOTTLE in 1 CARTON (42794-003-08) / 30 TABLET in 1 BOTTLE 1 bottle 2016-07-18 0000-00-00 No No Current