Home NDC 0228-2597 Indapamide
Product NDC 0228-2597
11-digit product format 002282597
Labeler code 0228
Product ID 0228-2597_c007dc5c-fc00-450f-8b79-3ab3038de5fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indapamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA074722
Marketing category ANDA
Marketing start 2007-01-02
Substance INDAPAMIDE
Active strength 1.25 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 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 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0228-2597 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0228-2597 0228-2597-00 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0228-2597 0228-2597-77 UNFINISHED Active or certified unfinished drug listing 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 · 39 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Indapamide
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197815 Internal RxNorm lookup 197816 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0228-2597-11 Indapamide 100 in 1 BOTTLE TABLET, FILM COATED 100 18 0228-2597-96 Indapamide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INDAPAMIDE ACTIVE INGREDIENT F089I0511L INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 INDAPAMIDE ACTIVE MOIETY F089I0511L INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 INDAPAMIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 INDAPAMIDE ACTIVE INGREDIENT F089I0511L INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 INDAPAMIDE ACTIVE MOIETY F089I0511L INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 INDAPAMIDE TABLET, FILM COATED [ACTAVIS ELIZABETH LLC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2597 INDAPAMIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20231027_a8a4ec2c-9d4b-482b-ad29-88185c96db74.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0228-2597-00 00228259700 68670 TABLET, FILM COATED in 1 BOX (0228-2597-00) 16-MAY-23 Current 0228-2597-11 00228259711 100 TABLET, FILM COATED in 1 BOTTLE (0228-2597-11) 2007-01-02 0000-00-00 No No Current 0228-2597-77 00228259777 82404 TABLET, FILM COATED in 1 CONTAINER (0228-2597-77) 07-AUG-24 Current 0228-2597-96 00228259796 1000 TABLET, FILM COATED in 1 BOTTLE (0228-2597-96) 2007-01-02 0000-00-00 No No Current