Home NDC 71335-0595-3 bisoprolol fumarate and hydrochlorothiazide
Product NDC 71335-0595
Requested package NDC 71335-0595-3
11-digit product format 713350595
Labeler code 71335
Product ID 71335-0595_c4dce7a9-9f15-483c-9d40-2de7ae0df8d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bisoprolol fumarate and hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA079106
Marketing category ANDA
Marketing start 2010-10-12
Substance HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE
Active strength 6.25; 5 mg/1; mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 132 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 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079106-002 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 5MG;6.25MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079106-003 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 10MG;6.25MG TABLET / ORAL AB 2010-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079106-001 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 2.5MG;6.25MG TABLET / ORAL AB 2010-07-28 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 bisoprolol fumarate and hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 6.25 mg/1 BISOPROLOL FUMARATE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0595-1 bisoprolol fumarate and hydrochlorothiazide 30 in 1 BOTTLE, PLASTIC TABLET 30 105 71335-0595-2 bisoprolol fumarate and hydrochlorothiazide 90 in 1 BOTTLE, PLASTIC TABLET 90 105 71335-0595-3 bisoprolol fumarate and hydrochlorothiazide 28 in 1 BOTTLE, PLASTIC TABLET 28 105 71335-0595-4 bisoprolol fumarate and hydrochlorothiazide 100 in 1 BOTTLE, PLASTIC TABLET 100 105
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0595 BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK] 105 Current NDC, Legacy NDC, 4 package rows 20240524_447c11b6-72fe-418e-a2db-5d90b5347796.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 71335-0595-3 71335059503 28 TABLET in 1 BOTTLE, PLASTIC (71335-0595-3) 28 tablet 2019-03-19 0000-00-00 No No Current