Home NDC 57664-655 Pindolol
Product NDC 57664-655
11-digit product format 576640655
Labeler code 57664
Product ID 57664-655_4d3c89dd-e947-5f23-e063-6294a90aeb1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pindolol
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074063
Marketing category ANDA
Marketing start 1994-01-27
Marketing end 2027-01-31
Substance PINDOLOL
Active strength 5 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
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 A074063-001 PINDOLOL PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 A074063-002 PINDOLOL PINDOLOL 10MG TABLET / ORAL AB 1994-01-27
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 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074063-001 PINDOLOL 5MG TABLET / ORAL AB 1994-01-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074063-002 PINDOLOL 10MG TABLET / ORAL AB 1994-01-27 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 Pindolol Active Ingredients# Ingredient, Strength table Ingredient Strength PINDOLOL 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BJ4HF6IU1D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198104 Internal RxNorm lookup 198105 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 57664-655-88 Pindolol 100 in 1 BOTTLE, PLASTIC TABLET 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Pindolol ACTIVE INGREDIENT BJ4HF6IU1D PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 Pindolol ACTIVE MOIETY BJ4HF6IU1D PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-655 PINDOLOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20210213_b331a73f-bf7b-4442-8901-36d016530279.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 · 3 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 57664-655-88 57664065588 100 TABLET in 1 BOTTLE, PLASTIC (57664-655-88) 100 tablet 1994-01-27 2027-01-31 No No Current