Home NDC 0115-5322 Nadolol and Bendroflumethiazide
Product NDC 0115-5322
11-digit product format 001155322
Labeler code 0115
Product ID 0115-5322_2669933a-33f4-478a-bd9d-9fe48429bcc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NADOLOL and BENDROFLUMETHIAZIDE
Dosage form TABLET
Route ORAL
Labeler Impax Generics
Application ANDA077833
Marketing category ANDA
Marketing start 2007-03-30
Marketing end 0000-00-00
Substance NADOLOL; BENDROFLUMETHIAZIDE
Active strength 80 mg/1; mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET / ORAL 2007-03-30 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG TABLET / ORAL 2007-03-30
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 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL 2007-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL 2007-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077833-001 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;40MG TABLET / ORAL AB 2007-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077833-002 NADOLOL AND BENDROFLUMETHIAZIDE 5MG;80MG TABLET / ORAL AB 2007-03-30 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-5322-01 Nadolol and Bendroflumethiazide 100 in 1 BOTTLE TABLET 100 6 0115-5322-02 Nadolol and Bendroflumethiazide 500 in 1 BOTTLE TABLET 500 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENDROFLUMETHIAZIDE ACTIVE INGREDIENT 5Q52X6ICJI NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 NADOLOL ACTIVE INGREDIENT FEN504330V NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 BENDROFLUMETHIAZIDE ACTIVE MOIETY 5Q52X6ICJI NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 NADOLOL ACTIVE MOIETY FEN504330V NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U NADOLOL AND BENDROFLUMETHIAZIDE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-5322 NADOLOL AND BENDROFLUMETHIAZIDE TABLET [IMPAX GENERICS] 6 Legacy NDC, 2 package rows 20160416_d2d226ea-1624-47ee-82bf-e9660b75029f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 0115-5322-01 00115532201 100 in 1 BOTTLE Historical 0115-5322-02 00115532202 500 in 1 BOTTLE Historical