Indapamide

Product NDC: 42291-348
Requested package NDC: 42291-348-90
11-digit product format: 422910348
Labeler code: 42291
Product ID: 42291-348_c7028a7f-5891-5476-e053-2995a90aec91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indapamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA074722
Marketing category: ANDA
Marketing start: 2016-02-09
Marketing end: 0000-00-00
Substance: INDAPAMIDE
Active strength: 1 mg/1
Pharmacologic classes: Increased Diuresis [PE],Thiazide-like Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42291-348	42291-348-90	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074722-001	INDAPAMIDE	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-06-17
A074722-002	INDAPAMIDE	INDAPAMIDE	2.5MG	TABLET / ORAL	AB		1996-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074722-001	AB
A074722-002	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
2026-08-18 06:07:40	2026-07	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074722-001	INDAPAMIDE	1.25MG	TABLET / ORAL	AB	1996-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074722-002	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	1996-06-17	`bb7c543d1eb4…`

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
2026-08-18 06:07:40	2026-07	A074722-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074722-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074722-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074722-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074722-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074722-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074722-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074722-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074722-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074722-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074722-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074722-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074722-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074722-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074722-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074722-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074722-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074722-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074722-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074722-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074722-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074722-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074722-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074722-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074722-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074722-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074722-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074722-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074722-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074722-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074722-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074722-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074722-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074722-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074722-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074722-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074722-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074722-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074722-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074722-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-348-90	EA - Each	42291-348	c54741cc-b6ed-4a4d-9eb0-2de298e5b6e3	1	2016-03-04

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indapamide	INDAPAMIDE	Preferred Pharmaceuticals Inc.	59cd3331-7afe-432a-8b50-39533fd5f392	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074722 application number: ANDA074722
Indapamide	INDAPAMIDE	Actavis Pharma, Inc.	a8a4ec2c-9d4b-482b-ad29-88185c96db74	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074722 application number: ANDA074722

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-348-90	42291034890	90 TABLET, FILM COATED in 1 BOTTLE (42291-348-90)	2016-02-09	0000-00-00	No	No	Current