Home NDC 69097-426 ENTECAVIR
Product NDC 69097-426
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 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A206872-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2016-12-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206872-002 ENTECAVIR 1MG TABLET / ORAL AB 2016-12-06 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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
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 69097-426-05 69097042605 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-426-05) 2016-12-06 0000-00-00 No No Current