Indapamide

Product NDC: 72162-1766
Requested package NDC: 72162-1766-1
11-digit product format: 721621766
Labeler code: 72162
Product ID: 72162-1766_4bc3f68d-e26e-4adb-e063-6294a90aa57f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indapamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074299
Marketing category: ANDA
Marketing start: 2017-04-24
Substance: INDAPAMIDE
Active strength: 1.25 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide-like Diuretic [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
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 72162-1766-1 ndc (product): 72162-1766 ndc11 (package): 72162176601
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

Additional Listing Data#

Finished product: Yes
Brand name base: Indapamide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDAPAMIDE	1.25 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
197815	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
8a16fc49-7a36-4873-9652-194ebb0bac68	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
72162-1766-1	Indapamide	100 in 1 BOTTLE	TABLET, FILM COATED	100		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1766-1	EA - Each	72162-1766	0fc6b1c1-67f6-4925-ba17-50a31800ddb7	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1766	INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	100	Current NDC, 1 package rows	20231006_8a16fc49-7a36-4873-9652-194ebb0bac68.zip

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
197815	indapamide 1.25 MG Oral Tablet	PSN	8a16fc49-7a36-4873-9652-194ebb0bac68	101
197815	indapamide 1.25 MG Oral Tablet	SCD	8a16fc49-7a36-4873-9652-194ebb0bac68	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-1766-1	72162176601	100 TABLET, FILM COATED in 1 BOTTLE (72162-1766-1)	2023-10-05	No	No	Current