Home NDC 0378-0069 Indapamide
Product NDC 0378-0069
11-digit product format 003780069
Labeler code 0378
Product ID 0378-0069_a92c5cdc-8cb6-44ad-ae7d-d6f415f1e8c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indapamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074461
Marketing category ANDA
Marketing start 1997-03-26
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 36 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 A074461-001 INDAPAMIDE INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 A074461-002 INDAPAMIDE INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26
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 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB 1996-03-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL AB RS 1996-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL AB 1997-03-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074461-001 INDAPAMIDE 2.5MG TABLET / ORAL 1996-03-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074461-002 INDAPAMIDE 1.25MG TABLET / ORAL 1997-03-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INDAPAMIDE ACTIVE INGREDIENT F089I0511L INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 INDAPAMIDE ACTIVE MOIETY F089I0511L INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 INDAPAMIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 INDAPAMIDE ACTIVE INGREDIENT F089I0511L INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 INDAPAMIDE ACTIVE MOIETY F089I0511L INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 INDAPAMIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 INDAPAMIDE ACTIVE INGREDIENT F089I0511L INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 INDAPAMIDE ACTIVE MOIETY F089I0511L INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 INDAPAMIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
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 · 1 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 0378-0069-01 00378006901 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0069-01) 1997-03-26 0000-00-00 No No Current 0378-0069-05 00378006905 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0069-05) 1997-03-26 0000-00-00 No No Current