Pindolol

Product NDC
72789-294
11-digit product format
727890294
Labeler code
72789
Product ID
72789-294_40bac889-265e-062b-e063-6394a90a9209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pindolol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074063-001PINDOLOLPINDOLOL5MGTABLET / ORALAB1994-01-27
A074063-002PINDOLOLPINDOLOL10MGTABLET / ORALAB1994-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074063-001AB
A074063-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074063-001PINDOLOL5MGTABLET / ORALAB1994-01-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A074063-002PINDOLOL10MGTABLET / ORALAB1994-01-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074063-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074063-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074063-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074063-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074063-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074063-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074063-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074063-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074063-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074063-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074063-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074063-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074063-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074063-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074063-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074063-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074063-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074063-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074063-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074063-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074063-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074063-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074063-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074063-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074063-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074063-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074063-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074063-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074063-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074063-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074063-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074063-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074063-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074063-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074063-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074063-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074063-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074063-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074063-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074063-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Pindolol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PINDOLOL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BJ4HF6IU1DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198105Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79a8d97b-9461-4914-bcbb-f6f64a39e5e7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
741bb9aa-d388-e012-0ad7-8a85bcbe396eProduct name420200121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-294-01Pindolol100 in 1 BOTTLE, PLASTICTABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-294-01EA - Each72789-294ed10e246-443f-4397-a703-5a93ddaf6f9f12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-294PINDOLOL TABLET [PD-RX PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20240207_79a8d97b-9461-4914-bcbb-f6f64a39e5e7.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PindololPINDOLOLPD-Rx Pharmaceuticals, Inc.0daed7b3-6017-4611-8c3a-2f390470f8bc2026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074063
application number: ANDA074063
PindololPINDOLOLPD-Rx Pharmaceuticals, Inc.79a8d97b-9461-4914-bcbb-f6f64a39e5e72026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074063
application number: ANDA074063
ndc (product): 72789-294
PindololPINDOLOLSun Pharmaceutical Industries, Inc.b331a73f-bf7b-4442-8901-36d0165302792026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074063
application number: ANDA074063

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198105pindolol 5 MG Oral TabletPSN79a8d97b-9461-4914-bcbb-f6f64a39e5e79
198105pindolol 5 MG Oral TabletSCD79a8d97b-9461-4914-bcbb-f6f64a39e5e79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-294-0172789029401100 TABLET in 1 BOTTLE, PLASTIC (72789-294-01) 100 tablet2023-01-110000-00-00NoNoCurrent