Home NDC 42494-458 ENTECAVIR
Product NDC 42494-458
11-digit product format 424940458
Labeler code 42494
Product ID 42494-458_3ada45bd-97aa-4713-ad29-6e462668c108
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENTECAVIR ANHYDROUS
Dosage form TABLET
Route ORAL
Labeler Cameron Pharmaceuticals
Application ANDA216857
Marketing category ANDA
Marketing start 2025-05-15
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 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 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 42494-458-30 ENTECAVIR 30 in 1 BOTTLE TABLET 30 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 42494-458-30 42494045830 30 TABLET in 1 BOTTLE (42494-458-30) 30 tablet 2025-05-15 No No Current