Home NDC 68382-921 Entecavir
Product NDC 68382-921
11-digit product format 683820921
Labeler code 68382
Product ID 68382-921_b9646f09-8d5b-4271-b2b1-b1d66a91ed73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entecavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA206745
Marketing category ANDA
Marketing start 2017-08-10
Substance ENTECAVIR
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 A206745-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 A206745-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23
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.
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 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206745-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2017-06-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206745-002 ENTECAVIR 1MG TABLET / ORAL AB 2017-06-23 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5968Y6H45M 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 68382-921-01 Entecavir 100 in 1 BOTTLE TABLET, FILM COATED 100 10 68382-921-06 Entecavir 30 in 1 BOTTLE TABLET, FILM COATED 30 10 68382-921-16 Entecavir 90 in 1 BOTTLE TABLET, FILM COATED 90 10 68382-921-30 Entecavir 10 in 1 BLISTER PACK TABLET, FILM COATED 10 10 68382-921-77 Entecavir 10 in 1 CARTON TABLET, FILM COATED 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-921 ENTECAVIR TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 5 package rows 20231011_b4fd0e22-ad23-4f51-9b98-95182f63c2eb.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 · 2 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 68382-921-01 68382092101 100 TABLET, FILM COATED in 1 BOTTLE (68382-921-01) 2017-08-10 0000-00-00 No No Current 68382-921-06 68382092106 30 TABLET, FILM COATED in 1 BOTTLE (68382-921-06) 2017-08-10 0000-00-00 No No Current 68382-921-16 68382092116 90 TABLET, FILM COATED in 1 BOTTLE (68382-921-16) 2017-08-10 0000-00-00 No No Current 68382-921-30 68382092130 10 in 1 BLISTER PACK Historical 68382-921-77 68382092177 10 BLISTER PACK in 1 CARTON (68382-921-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-921-30) 10 blister pack 2017-08-10 0000-00-00 No No Current