Irbesartan

Product NDC
70518-1543
11-digit product format
705181543
Labeler code
70518
Product ID
70518-1543_494be1b4-f986-f70d-e063-6294a90a1704
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203071
Marketing category
ANDA
Marketing start
2018-10-17
Substance
IRBESARTAN
Active strength
300 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-154370518-1543-0DDiscontinued by firm2026-08-11

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 · 23 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-1543-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1543-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1543-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1543-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1543-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1543-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1543-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1543-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1543-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1543-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1543-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1543-0557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203071-001IRBESARTANIRBESARTAN75MGTABLET / ORALAB2012-09-27
A203071-002IRBESARTANIRBESARTAN150MGTABLET / ORALAB2012-09-27
A203071-003IRBESARTANIRBESARTAN300MGTABLET / ORALAB2012-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203071-001AB
A203071-002AB
A203071-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203071-002IRBESARTAN150MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203071-003IRBESARTAN300MGTABLET / ORALAB2012-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203071-001IRBESARTAN75MGTABLET / ORALAB2012-09-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203071-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203071-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203071-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203071-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203071-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203071-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203071-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203071-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203071-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203071-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203071-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203071-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203071-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203071-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203071-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203071-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203071-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203071-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203071-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203071-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203071-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203071-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203071-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203071-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203071-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203071-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203071-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203071-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203071-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203071-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203071-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203071-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203071-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203071-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203071-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203071-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203071-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203071-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203071-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203071-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRBESARTAN300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J0E2756Z7NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200096Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9adacfa2-2814-4deb-9e34-c3b3c8dcd41aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1543-0Irbesartan90 in 1 BOTTLE, PLASTICTABLET906
70518-1543-1Irbesartan90 in 1 BOTTLE, PLASTICTABLET906

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
IrbesartanIRBESARTANREMEDYREPACK INC.029a90b6-0722-49be-8400-3ec29526aafd2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANREMEDYREPACK INC.9adacfa2-2814-4deb-9e34-c3b3c8dcd41a2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
ndc (product): 70518-1543
IrbesartanIRBESARTANBryant Ranch Prepack14d85774-2d74-4300-b4bb-c2836db4d5bd2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANSolco Healthcare U.S., LLC6916c617-92d2-44f5-b968-6267517a2ce62025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANA-S Medication Solutions70a25c6d-23ce-488c-9ef8-62b3b99e50522025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANA-S Medication Solutions6babdb48-8384-49ce-a759-d380d79a40102025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANBryant Ranch Prepackecc490ea-a68e-4261-8be2-5020ac5ab8032024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANBryant Ranch Prepackefcd5f2e-1837-44ae-bc91-410c4d8b27c72023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANBryant Ranch Prepack1ab1ff46-d0b1-4762-9ebf-3e07dde8b0482023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071
IrbesartanIRBESARTANProficient Rx LPb587d89b-8ff9-4180-b31a-bbff5d365a1d2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203071
application number: ANDA203071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200096irbesartan 300 MG Oral TabletPSN9adacfa2-2814-4deb-9e34-c3b3c8dcd41a6
200096irbesartan 300 MG Oral TabletSCD9adacfa2-2814-4deb-9e34-c3b3c8dcd41a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1543-07051815430090 in 1 BOTTLE, PLASTICHistorical
70518-1543-17051815430190 TABLET in 1 BOTTLE, PLASTIC (70518-1543-1) 90 tablet2025-09-08NoNoCurrent