Indapamide

Product NDC: 55700-641
11-digit product format: 557000641
Labeler code: 55700
Product ID: 55700-641_84d834e9-22da-4ac8-988c-571340544957
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indapamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA074299
Marketing category: ANDA
Marketing start: 2018-06-15
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-641		D	Discontinued by firm		2026-08-17
excluded package	package	55700-641	55700-641-90	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-641-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-641-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55700-641-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55700-641-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55700-641-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55700-641-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55700-641-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55700-641-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55700-641-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55700-641-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55700-641-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55700-641-90	`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
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 · 84 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
2026-08-18 06:07:40	2026-07	A074299-001	INDAPAMIDE	2.5MG	TABLET / ORAL	AB	RS	1995-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074299-002	INDAPAMIDE	1.25MG	TABLET / ORAL	AB		1996-04-29	`caaa826d4ba7…`
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…`

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	A074299-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074299-002	AB	1	`caaa826d4ba7…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-641-90	EA - Each	55700-641	79f3dddf-f1c9-4939-bf0f-049748ccfb5d	1	2018-07-03

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indapamide Tablets USP Rx only	Lake Erie Medical DBA Quality Care Products LLC	2019-11-14	HUMAN PRESCRIPTION DRUG LABEL	4