Pindolol

Product NDC: 82804-940
11-digit product format: 828040940
Labeler code: 82804
Product ID: 82804-940_b7e273a6-e810-4a03-88cd-ff3376e244c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pindolol
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
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: 2027-12-31
Current FDA listing: Yes

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
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.

Application-product, TE code table
Application-product	TE code
A205415-001	AB
A205415-002	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205415-001	PINDOLOL	5MG	TABLET / ORAL	AB	2016-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205415-002	PINDOLOL	10MG	TABLET / ORAL	AB	2016-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205415-001	PINDOLOL	5MG	TABLET / ORAL	AB	2016-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205415-002	PINDOLOL	10MG	TABLET / ORAL	AB	2016-01-13	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205415-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205415-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205415-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205415-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205415-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205415-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205415-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205415-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205415-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205415-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205415-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205415-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205415-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205415-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205415-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205415-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205415-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205415-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205415-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205415-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205415-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205415-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205415-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205415-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205415-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205415-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205415-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205415-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205415-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205415-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205415-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205415-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205415-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205415-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205415-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205415-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205415-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205415-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205415-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205415-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pindolol	PINDOLOL	Bryant Ranch Prepack	8498aead-0aef-4cd8-a191-05cae57a55e5	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205415 application number: ANDA205415
Pindolol	PINDOLOL	Bryant Ranch Prepack	22b95e96-ead9-4149-badb-7d33077e82ec	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205415 application number: ANDA205415
Pindolol	PINDOLOL	Westminster Pharmaceuticals, LLC	efdb0189-37b5-45d6-b92c-1157bb9df789	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205415 application number: ANDA205415

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BJ4HF6IU1D	PINDOLOL	13523-86-9	PINDOLOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-940-00	82804094000	100 TABLET in 1 BOTTLE (82804-940-00)	100 tablet	2026-09-17	No	No	Current
82804-940-30	82804094030	30 TABLET in 1 BOTTLE (82804-940-30)	30 tablet	2026-09-17	No	No	Current
82804-940-55	82804094055	500 TABLET in 1 BOTTLE (82804-940-55)	500 tablet	2026-09-17	No	No	Current
82804-940-60	82804094060	60 TABLET in 1 BOTTLE (82804-940-60)	60 tablet	2026-09-17	No	No	Current
82804-940-72	82804094072	120 TABLET in 1 BOTTLE (82804-940-72)	120 tablet	2026-09-17	No	No	Current
82804-940-78	82804094078	180 TABLET in 1 BOTTLE (82804-940-78)	180 tablet	2026-09-17	No	No	Current
82804-940-90	82804094090	90 TABLET in 1 BOTTLE (82804-940-90)	90 tablet	2026-09-17	No	No	Current