Home NDC 69367-422 Pindolol
Product NDC 69367-422
11-digit product format 693670422
Labeler code 69367
Product ID 69367-422_cd3e9748-5b81-47f6-881c-648b3e2c4d3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pindolol
Dosage form TABLET
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA205415
Marketing category ANDA
Marketing start 2025-11-18
Substance PINDOLOL
Active strength 10 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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 A205415-001 PINDOLOL PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 A205415-002 PINDOLOL PINDOLOL 10MG TABLET / ORAL AB 2016-01-13
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 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205415-001 PINDOLOL 5MG TABLET / ORAL AB 2016-01-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205415-002 PINDOLOL 10MG TABLET / ORAL AB 2016-01-13 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PINDOLOL 10 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 69367-422-01 Pindolol 100 in 1 BOTTLE TABLET 100 1
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 Sample Exclude flag Status 69367-422-01 69367042201 100 TABLET in 1 BOTTLE (69367-422-01) 100 tablet 2025-11-18 No No Current