Indapamide

Product NDC
68788-7247
11-digit product format
687887247
Labeler code
68788
Product ID
68788-7247_821a8777-e8a6-4cac-9936-7ba9615ae44a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA074722
Marketing category
ANDA
Marketing start
2018-08-20
Substance
INDAPAMIDE
Active strength
2.5 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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074722-001INDAPAMIDEINDAPAMIDE1.25MGTABLET / ORALAB1996-06-17
A074722-002INDAPAMIDEINDAPAMIDE2.5MGTABLET / ORALAB1996-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074722-001AB
A074722-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074722-001INDAPAMIDE1.25MGTABLET / ORALAB1996-06-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074722-002INDAPAMIDE2.5MGTABLET / ORALAB1996-06-17bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074722-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074722-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074722-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074722-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074722-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074722-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074722-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074722-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074722-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074722-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074722-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074722-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074722-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074722-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074722-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074722-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074722-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074722-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074722-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074722-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074722-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074722-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074722-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074722-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074722-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074722-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074722-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074722-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074722-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074722-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074722-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074722-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074722-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074722-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074722-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074722-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074722-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074722-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074722-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074722-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDAPAMIDE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F089I0511LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197816Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59cd3331-7afe-432a-8b50-39533fd5f392Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bda0d04-c82b-7786-6ed9-2a416b849e7aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7247-1Indapamide100 in 1 BOTTLETABLET, FILM COATED1009
68788-7247-3Indapamide30 in 1 BOTTLETABLET, FILM COATED309
68788-7247-6Indapamide60 in 1 BOTTLETABLET, FILM COATED609
68788-7247-9Indapamide90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7247-1EA - Each68788-72470689f1c3-fa87-454d-a1c4-33b1c0a8248e12018-11-06
68788-7247-3EA - Each68788-7247f0b46ebb-20ac-48e0-a21b-f31e2cb7b6e912018-11-06
68788-7247-6EA - Each68788-7247e431706f-70d8-42a0-88ff-eb8956cb2bed12018-11-06
68788-7247-9EA - Each68788-72477c3e1d94-2ce0-46cf-a216-5b3390cf741312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7247INDAPAMIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 4 package rows20240526_59cd3331-7afe-432a-8b50-39533fd5f392.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndapamideINDAPAMIDEPreferred Pharmaceuticals Inc.59cd3331-7afe-432a-8b50-39533fd5f3922026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074722
application number: ANDA074722
ndc (product): 68788-7247
IndapamideINDAPAMIDEActavis Pharma, Inc.a8a4ec2c-9d4b-482b-ad29-88185c96db742022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074722
application number: ANDA074722

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197816indapamide 2.5 MG Oral TabletPSN59cd3331-7afe-432a-8b50-39533fd5f3929
197816indapamide 2.5 MG Oral TabletSCD59cd3331-7afe-432a-8b50-39533fd5f3929
197816indapamide (as indapamide hemihydrate) 2.5 MG Oral TabletSY59cd3331-7afe-432a-8b50-39533fd5f3929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7247-168788724701100 TABLET, FILM COATED in 1 BOTTLE (68788-7247-1) 2018-08-200000-00-00NoNoCurrent
68788-7247-36878872470330 TABLET, FILM COATED in 1 BOTTLE (68788-7247-3) 2018-08-200000-00-00NoNoCurrent
68788-7247-66878872470660 TABLET, FILM COATED in 1 BOTTLE (68788-7247-6) 2018-08-200000-00-00NoNoCurrent
68788-7247-96878872470990 TABLET, FILM COATED in 1 BOTTLE (68788-7247-9) 2018-08-200000-00-00NoNoCurrent