Home NDC 0003-1611 BARACLUDE
Product NDC 0003-1611
11-digit product format 000031611
Labeler code 0003
Product ID 0003-1611_275a2584-65d6-40f8-8aac-49eb54479f6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name entecavir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA021797
Marketing category NDA
Marketing start 2005-03-29
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021797-001 BARACLUDE ENTECAVIR 0.5MG TABLET / ORAL AB RLD 2005-03-29 N021797-002 BARACLUDE ENTECAVIR 1MG TABLET / ORAL AB RLD, RS 2005-03-29
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 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021797-001 BARACLUDE 0.5MG TABLET / ORAL AB RLD 2005-03-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021797-002 BARACLUDE 1MG TABLET / ORAL AB RLD, RS 2005-03-29 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 BARACLUDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTECAVIR .5 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485434 Internal RxNorm lookup 485436 Internal RxNorm lookup 485536 Internal RxNorm lookup 578457 Internal RxNorm lookup 578459 Internal RxNorm lookup 607579 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 0003-1611-12 BARACLUDE 30 in 1 BOTTLE TABLET, FILM COATED 30 42 0003-1611-12 BARACLUDE 1 in 1 CARTON TABLET, FILM COATED 1 42 0003-1611-13 BARACLUDE 1 in 1 CARTON TABLET, FILM COATED 1 42 0003-1611-13 BARACLUDE 90 in 1 BOTTLE TABLET, FILM COATED 90 42
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded entecavir ACTIVE INGREDIENT 5968Y6H45M BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 entecavir anhydrous ACTIVE MOIETY NNU2O4609D BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 crospovidone INACTIVE INGREDIENT 68401960MK BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 maltitol INACTIVE INGREDIENT D65DG142WK BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 methylparaben INACTIVE INGREDIENT A2I8C7HI9T BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 POVIDONES INACTIVE INGREDIENT FZ989GH94E BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 30
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-1611 BARACLUDE (ENTECAVIR) TABLET, FILM COATED BARACLUDE (ENTECAVIR) SOLUTION [E.R. SQUIBB & SONS, L.L.C.] 41 Current NDC, Legacy NDC, 4 package rows 20240510_046e61c9-9298-4b2e-b76e-b26b81fecd20.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 0003-1611-12 00003161112 1 BOTTLE in 1 CARTON (0003-1611-12) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2005-03-29 0000-00-00 No No Current 0003-1611-13 00003161113 1 in 1 CARTON Historical