Home NDC 43547-437 ENTECAVIR
Product NDC 43547-437
11-digit product format 435470437
Labeler code 43547
Product ID 43547-437_a5a51ce6-2c18-40de-b266-c3891132bbd1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENTECAVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Solco Healthcare LLC
Application ANDA208782
Marketing category ANDA
Marketing start 2018-04-01
Substance ENTECAVIR ANHYDROUS
Active strength 1 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208782-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 A208782-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL 2017-10-10
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 3 · 82 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 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL 2017-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208782-002 ENTECAVIR 1MG TABLET / ORAL 2017-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208782-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-10-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208782-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-10-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ENTECAVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTECAVIR ANHYDROUS 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NNU2O4609D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485434 Internal RxNorm lookup 485436 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 43547-437-03 ENTECAVIR 30 in 1 BOTTLE TABLET, FILM COATED 30 10 43547-437-09 ENTECAVIR 90 in 1 BOTTLE TABLET, FILM COATED 90 10 43547-437-50 ENTECAVIR 500 in 1 BOTTLE TABLET, FILM COATED 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-437 ENTECAVIR TABLET, FILM COATED [SOLCO HEALTHCARE LLC] 9 Current NDC, Legacy NDC, 3 package rows 20240801_bb1bb6dc-0120-46e2-ad1e-d9afc221fa16.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 Marketing start Marketing end Sample Exclude flag Status 43547-437-03 43547043703 30 TABLET, FILM COATED in 1 BOTTLE (43547-437-03) 2018-04-01 0000-00-00 No No Current 43547-437-09 43547043709 90 TABLET, FILM COATED in 1 BOTTLE (43547-437-09) 2018-04-01 0000-00-00 No No Current 43547-437-15 43547043715 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-15) 2018-04-01 0000-00-00 No No Current 43547-437-50 43547043750 500 TABLET, FILM COATED in 1 BOTTLE (43547-437-50) 2018-04-01 0000-00-00 No No Current