Home NDC 72789-099 Pindolol
Product NDC 72789-099
11-digit product format 727890099
Labeler code 72789
Product ID 72789-099_48330d07-3d23-affa-e063-6394a90ac6af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pindolol
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA211712
Marketing category ANDA
Marketing start 2020-02-01
Substance PINDOLOL
Active strength 10 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A211712-001 PINDOLOL PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 A211712-002 PINDOLOL PINDOLOL 10MG TABLET / ORAL AB 2019-08-01
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 2 · 80 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 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211712-001 PINDOLOL 5MG TABLET / ORAL AB 2019-08-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211712-002 PINDOLOL 10MG TABLET / ORAL AB 2019-08-01 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pindolol
Listing expiration 2027-12-31 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 72789-099-01 Pindolol 100 in 1 BOTTLE, PLASTIC TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-099 PINDOLOL TABLET [PD-RX PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241010_f91e5715-e37d-45fa-97a7-4d32fbd51060.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 72789-099-01 72789009901 100 TABLET in 1 BOTTLE, PLASTIC (72789-099-01) 100 tablet 2020-07-15 0000-00-00 No No Current