Ambrisentan

Product NDC
60505-4552
11-digit product format
605054552
Labeler code
60505
Product ID
60505-4552_9ea6cb4f-0099-f884-4d51-8335310bf1b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMBRISENTAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA210701
Marketing category
ANDA
Marketing start
2022-09-19
Substance
AMBRISENTAN
Active strength
5 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-455260505-4552-0DDiscontinued by firm2026-08-11
excluded packagepackage60505-455260505-4552-1DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0560505-4552-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-4552-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2660505-4552-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-4552-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3160505-4552-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-4552-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2860505-4552-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-4552-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2160505-4552-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-4552-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1060505-4552-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-4552-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3160505-4552-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-4552-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2060505-4552-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-4552-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1060505-4552-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-4552-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0860505-4552-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-4552-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0360505-4552-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0360505-4552-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0960505-4552-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0960505-4552-0557ba5c1ecfa…9c80585c8c6e…

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
A210701-001AMBRISENTANAMBRISENTAN5MGTABLET / ORALAB2022-05-19
A210701-002AMBRISENTANAMBRISENTAN10MGTABLET / ORALAB2022-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210701-001AB
A210701-002AB

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 2 · 58 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-195c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-196a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-191c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-19a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210701-001AMBRISENTAN5MGTABLET / ORALAB2022-05-199b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210701-002AMBRISENTAN10MGTABLET / ORALAB2022-05-199b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210701-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210701-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210701-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210701-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210701-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210701-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210701-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210701-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210701-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210701-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210701-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210701-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210701-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210701-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210701-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210701-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210701-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210701-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210701-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210701-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210701-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210701-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210701-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210701-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210701-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210701-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210701-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210701-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210701-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210701-002AB15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210701-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210701-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210701-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210701-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210701-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A210701-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210701-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210701-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210701-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210701-002AB19b2671bbb829…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBRISENTAN5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HW6NV07QECInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
722116Internal RxNorm lookup
722122Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
291a782a-77e1-8a8e-e1c8-2626f305c2b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d7db2b61-402f-f2c9-6e9c-10d81037d0baProduct name320230126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4552-0Ambrisentan1 in 1 CARTONTABLET, FILM COATED19
60505-4552-0Ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED109
60505-4552-1Ambrisentan10 in 1 BLISTER PACKTABLET, FILM COATED109
60505-4552-1Ambrisentan3 in 1 CARTONTABLET, FILM COATED39
60505-4552-3Ambrisentan30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4552-3EA - Each60505-45522af73808-f8fe-4e6c-83b5-39a96e72a5ca12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4552AMBRISENTAN TABLET, FILM COATED [APOTEX CORP.]6Current NDC, Legacy NDC, 5 package rows20250501_291a782a-77e1-8a8e-e1c8-2626f305c2b7.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
AmbrisentanAMBRISENTANGolden State Medical Supply, Inc.4396bab5-2851-62ef-e063-6294a90af76e2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210701
application number: ANDA210701
AmbrisentanAMBRISENTANApotex Corp.291a782a-77e1-8a8e-e1c8-2626f305c2b72025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210701
application number: ANDA210701
ndc (product): 60505-4552

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722116ambrisentan 10 MG Oral TabletPSN291a782a-77e1-8a8e-e1c8-2626f305c2b79
722122ambrisentan 5 MG Oral TabletPSN291a782a-77e1-8a8e-e1c8-2626f305c2b79
722116ambrisentan 10 MG Oral TabletSCD291a782a-77e1-8a8e-e1c8-2626f305c2b79
722122ambrisentan 5 MG Oral TabletSCD291a782a-77e1-8a8e-e1c8-2626f305c2b79
722116ambrisentan 10 MG Oral TabletPSN4396bab5-2851-62ef-e063-6294a90af76e3
722122ambrisentan 5 MG Oral TabletPSN4396bab5-2851-62ef-e063-6294a90af76e3
722116ambrisentan 10 MG Oral TabletSCD4396bab5-2851-62ef-e063-6294a90af76e3
722122ambrisentan 5 MG Oral TabletSCD4396bab5-2851-62ef-e063-6294a90af76e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4552-0605054552001 in 1 CARTONHistorical
60505-4552-16050545520110 in 1 BLISTER PACKHistorical
60505-4552-36050545520330 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3) 2022-09-190000-00-00NoNoCurrent