Pindolol

Product NDC: 72789-099
Requested package NDC: 72789-099-01
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 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
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.

Application-product, TE code table
Application-product	TE code
A211712-001	AB
A211712-002	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 · 84 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	A211712-001	PINDOLOL	5MG	TABLET / ORAL	AB	2019-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211712-002	PINDOLOL	10MG	TABLET / ORAL	AB	2019-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211712-001	PINDOLOL	5MG	TABLET / ORAL	AB	2019-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211712-002	PINDOLOL	10MG	TABLET / ORAL	AB	2019-08-01	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A211712-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211712-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211712-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211712-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211712-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211712-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211712-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211712-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211712-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211712-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211712-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211712-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211712-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211712-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211712-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211712-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211712-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211712-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211712-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211712-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211712-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211712-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211712-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211712-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211712-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211712-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211712-002	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

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f91e5715-e37d-45fa-97a7-4d32fbd51060	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
741bb9aa-d388-e012-0ad7-8a85bcbe396e	Product name	4	20200121

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	f91e5715-e37d-45fa-97a7-4d32fbd51060	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211712 application number: ANDA211712 ndc (package): 72789-099-01 ndc (product): 72789-099 ndc11 (package): 72789009901
Pindolol	PINDOLOL	Unichem Pharmaceuticals (USA), Inc.	f529ff35-f82b-4a3a-96b4-096bfc8e81b5	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211712 application number: ANDA211712
Pindolol	PINDOLOL	Bryant Ranch Prepack	7fb36f8f-11fe-498e-8667-daeccf8b2273	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211712 application number: ANDA211712

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198104	pindolol 10 MG Oral Tablet	PSN	f91e5715-e37d-45fa-97a7-4d32fbd51060	10
198105	pindolol 5 MG Oral Tablet	PSN	f91e5715-e37d-45fa-97a7-4d32fbd51060	10
198104	pindolol 10 MG Oral Tablet	SCD	f91e5715-e37d-45fa-97a7-4d32fbd51060	10
198105	pindolol 5 MG Oral Tablet	SCD	f91e5715-e37d-45fa-97a7-4d32fbd51060	10

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pindolol Tablets, USP 5 mg and 10 mg Rx Only	PD-Rx Pharmaceuticals, Inc.	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL	10