Home NDC 42806-667-30 Entecavir
Product NDC 42806-667
Requested package NDC 42806-667-30
11-digit product format 428060667
Labeler code 42806
Product ID 42806-667_d69451df-e204-4a5c-a2bb-9e6d4d519302
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name entecavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA216857
Marketing category ANDA
Marketing start 2022-10-31
Substance ENTECAVIR ANHYDROUS
Active strength .5 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 2027-12-31
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 A216857-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 A216857-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216857-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2024-12-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216857-002 ENTECAVIR 1MG TABLET / ORAL AB 2024-12-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Entecavir
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTECAVIR ANHYDROUS .5 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 42806-667-30 Entecavir 30 in 1 BOTTLE TABLET, FILM COATED 30 1 42806-667-30 Entecavir 1 in 1 CARTON TABLET, FILM COATED 1 1
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 Units Marketing start Sample Exclude flag Status 42806-667-30 42806066730 1 BOTTLE in 1 CARTON (42806-667-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-11-01 No No Current