Home NDC 69097-426-02 ENTECAVIR
Product NDC 69097-426
Requested package NDC 69097-426-02
11-digit product format 690970426
Labeler code 69097
Product ID 69097-426_6766d9ae-3639-4bc7-9488-5bf52fe49420
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ENTECAVIR
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA206872
Marketing category ANDA
Marketing start 2016-12-06
Substance ENTECAVIR
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 43 .
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 A206872-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 A206872-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06
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 · 86 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 2026-09-14 22:38:34 2026-08 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ENTECAVIR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTECAVIR .5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-426-02 ENTECAVIR 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 16 69097-426-05 ENTECAVIR 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-426 ENTECAVIR TABLET, FILM COATED [CIPLA USA INC.] 16 Current NDC, Legacy NDC, 2 package rows 20221227_d59e9ea4-09ea-47bd-af2f-39f7a2e2aceb.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENTECAVIR ENTECAVIR NorthStar RxLLC da705339-c349-444f-a058-4f0cef2864bf 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206872 application number: ANDA206872
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 69097-426-02 69097042602 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-426-02) 2016-12-06 0000-00-00 No No Current