Indapamide

Product NDC: 72189-591
Requested package NDC: 72189-591-60
11-digit product format: 721890591
Labeler code: 72189
Product ID: 72189-591_25b5bb79-400e-e266-e063-6394a90abfd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indapamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA074299
Marketing category: ANDA
Marketing start: 2024-10-30
Substance: INDAPAMIDE
Active strength: 2.5 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide-like Diuretic [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
A074299-001	INDAPAMIDE	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27
A074299-002	INDAPAMIDE	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074299-001	AB
A074299-002	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 · 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	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB		1995-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074299-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074299-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074299-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074299-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074299-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074299-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074299-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074299-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074299-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074299-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074299-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074299-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074299-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074299-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074299-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074299-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074299-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074299-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074299-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074299-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074299-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074299-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074299-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074299-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074299-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074299-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074299-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074299-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074299-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074299-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074299-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074299-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074299-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074299-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074299-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074299-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074299-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074299-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074299-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074299-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Indapamide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDAPAMIDE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F089I0511L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197816	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
25b5bb79-400d-e266-e063-6394a90abfd8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2bda0d04-c82b-7786-6ed9-2a416b849e7a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-591-60	Indapamide	60 in 1 BOTTLE	TABLET, FILM COATED	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-591	INDAPAMIDE TABLET, FILM COATED [DIRECT_RX]	1	Current NDC, 1 package rows	20241101_25b5bb79-400d-e266-e063-6394a90abfd8.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	8a16fc49-7a36-4873-9652-194ebb0bac68	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	5b55449f-4242-489d-8ba7-5baf4ba1a53a	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	962b20df-88ff-4ab7-a900-135adb6c1d74	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	A-S Medication Solutions	7fe643f7-a1df-4e9a-9d45-f20b8512a04e	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	A-S Medication Solutions	c678bc6b-a01b-4238-8bcb-490bc6d41d72	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	Golden State Medical Supply, Inc.	71feffd5-4056-2b53-e053-2995a90a5b73	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	365d26ea-d02d-4fcf-9c99-54c251ef0483	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	Bryant Ranch Prepack	6a643c56-794a-4289-8390-5d76fa2709b3	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	ANI Pharmaceuticals, Inc.	deb83f97-6c61-4a09-bed6-18dcf1183405	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299
Indapamide	INDAPAMIDE	Direct_Rx	25b5bb79-400d-e266-e063-6394a90abfd8	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074299 application number: ANDA074299 ndc (package): 72189-591-60 ndc (product): 72189-591 ndc11 (package): 72189059160

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F089I0511L	INDAPAMIDE	26807-65-8	INDAPAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197816	indapamide 2.5 MG Oral Tablet	PSN	25b5bb79-400d-e266-e063-6394a90abfd8	1
197816	indapamide 2.5 MG Oral Tablet	SCD	25b5bb79-400d-e266-e063-6394a90abfd8	1
197816	indapamide (as indapamide hemihydrate) 2.5 MG Oral Tablet	SY	25b5bb79-400d-e266-e063-6394a90abfd8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-591-60	72189059160	60 TABLET, FILM COATED in 1 BOTTLE (72189-591-60)	2024-10-30	No	No	Current