Home NDC 31722-833 Entecavir
Product NDC 31722-833
11-digit product format 317220833
Labeler code 31722
Product ID 31722-833_2b442999-71b5-88f6-e063-6394a90a9d6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entecavir
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA205740
Marketing category ANDA
Marketing start 2015-08-21
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 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 A205740-001 ENTECAVIR ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 A205740-002 ENTECAVIR ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21
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 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205740-001 ENTECAVIR 0.5MG TABLET / ORAL AB 2015-08-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205740-002 ENTECAVIR 1MG TABLET / ORAL AB 2015-08-21 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 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 31722-833-30 Entecavir 30 in 1 BOTTLE TABLET 30 4 31722-833-31 Entecavir 10 in 1 BLISTER PACK TABLET 10 4 31722-833-32 Entecavir 100 in 1 CARTON TABLET 100 4 31722-833-90 Entecavir 90 in 1 BOTTLE TABLET 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ENTECAVIR ANHYDROUS ACTIVE INGREDIENT NNU2O4609D ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 ENTECAVIR ANHYDROUS ACTIVE MOIETY NNU2O4609D ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 THIAMINE MONONITRATE INACTIVE INGREDIENT 8K0I04919X ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-833 ENTECAVIR (ENTECAVIR) TABLET ENTECAVIR TABLET [CAMBER PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20250112_01ec50a1-6c6c-46f0-8c74-73542b0a59c3.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.
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 31722-833-30 31722083330 30 TABLET in 1 BOTTLE (31722-833-30) 30 tablet 2015-08-21 0000-00-00 No No Current 31722-833-31 31722083331 10 TABLET in 1 BLISTER PACK (31722-833-31) 10 tablet 2015-08-21 0000-00-00 No No Current 31722-833-32 31722083332 100 TABLET in 1 CARTON (31722-833-32) 100 tablet 2015-08-21 0000-00-00 No No Current 31722-833-90 31722083390 90 TABLET in 1 BOTTLE (31722-833-90) 90 tablet 2015-08-21 0000-00-00 No No Current