Indapamide

Product NDC
51407-025
Requested package NDC
51407-025-01
11-digit product format
514070025
Labeler code
51407
Product ID
51407-025_43fb71bf-afb5-1e01-e063-6294a90ac60e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA074299
Marketing category
ANDA
Marketing start
1995-07-27
Substance
INDAPAMIDE
Active strength
2.5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074299-001INDAPAMIDEINDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27
A074299-002INDAPAMIDEINDAPAMIDE1.25MGTABLET / ORALAB1996-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074299-001AB
A074299-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074299-001INDAPAMIDE2.5MGTABLET / ORALAB1995-07-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074299-001INDAPAMIDE2.5MGTABLET / ORALABRS1995-07-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A074299-002INDAPAMIDE1.25MGTABLET / ORALAB1996-04-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074299-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074299-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074299-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074299-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074299-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074299-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074299-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074299-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074299-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074299-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074299-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074299-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074299-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074299-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074299-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074299-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074299-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074299-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074299-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074299-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074299-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074299-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074299-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074299-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074299-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074299-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074299-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074299-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074299-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074299-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074299-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074299-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074299-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074299-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074299-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074299-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074299-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074299-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074299-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A074299-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Indapamide
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197815Internal RxNorm lookup
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
71feffd5-4056-2b53-e053-2995a90a5b73Available 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
51407-025-01Indapamide100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-025-01EA - Each51407-02561efb852-b3c5-4563-83b6-172a0e78b5d212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-025INDAPAMIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 1 package rows20240907_71feffd5-4056-2b53-e053-2995a90a5b73.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IndapamideINDAPAMIDEBryant Ranch Prepack8a16fc49-7a36-4873-9652-194ebb0bac682026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEBryant Ranch Prepack5b55449f-4242-489d-8ba7-5baf4ba1a53a2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEBryant Ranch Prepack962b20df-88ff-4ab7-a900-135adb6c1d742026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEA-S Medication Solutions7fe643f7-a1df-4e9a-9d45-f20b8512a04e2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEA-S Medication Solutionsc678bc6b-a01b-4238-8bcb-490bc6d41d722025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEGolden State Medical Supply, Inc.71feffd5-4056-2b53-e053-2995a90a5b732025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
ndc (package): 51407-025-01
ndc (product): 51407-025
ndc11 (package): 51407002501
IndapamideINDAPAMIDEBryant Ranch Prepack365d26ea-d02d-4fcf-9c99-54c251ef04832025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEBryant Ranch Prepack6a643c56-794a-4289-8390-5d76fa2709b32025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEANI Pharmaceuticals, Inc.deb83f97-6c61-4a09-bed6-18dcf11834052025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299
IndapamideINDAPAMIDEDirect_Rx25b5bb79-400d-e266-e063-6394a90abfd82024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074299
application number: ANDA074299

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197815indapamide 1.25 MG Oral TabletPSN71feffd5-4056-2b53-e053-2995a90a5b739
197816indapamide 2.5 MG Oral TabletPSN71feffd5-4056-2b53-e053-2995a90a5b739
197815indapamide 1.25 MG Oral TabletSCD71feffd5-4056-2b53-e053-2995a90a5b739
197816indapamide 2.5 MG Oral TabletSCD71feffd5-4056-2b53-e053-2995a90a5b739
197816indapamide (as indapamide hemihydrate) 2.5 MG Oral TabletSY71feffd5-4056-2b53-e053-2995a90a5b739

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-025-0151407002501100 TABLET, FILM COATED in 1 BOTTLE (51407-025-01) 2018-01-010000-00-00NoNoCurrent