Aromasin

Product NDC
0009-7663
11-digit product format
000097663
Labeler code
0009
Product ID
0009-7663_aacc35a2-0e82-4ba7-bec1-297802d4fa44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
exemestane
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA020753
Marketing category
NDA
Marketing start
1999-10-21
Substance
EXEMESTANE
Active strength
25 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020753-001AROMASINEXEMESTANE25MGTABLET / ORALABRLD, RS1999-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020753-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-213f01610625f2…
2019-09-15 20:21 UTC2019-09N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020753-001AROMASIN25MGTABLET / ORALABRLD, RS1999-10-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020753-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020753-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020753-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020753-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020753-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020753-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020753-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020753-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020753-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020753-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020753-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020753-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020753-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020753-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020753-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020753-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020753-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020753-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020753-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020753-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020753-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020753-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020753-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020753-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020753-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020753-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020753-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020753-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020753-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020753-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020753-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020753-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020753-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020753-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020753-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020753-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020753-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020753-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020753-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020753-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EXEMESTANE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NY22HMQ4BXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
261317Internal RxNorm lookup
310261Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf066b7a-032a-416c-8d40-15ba581423e3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1fe6d34b-d50f-eeb9-bd0c-3f0d6b635985Product name920230126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-7663-04Aromasin30 in 1 BOTTLETABLET3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-7663-04EA - Each0009-76632f663671-c244-4163-b98f-a2ad9726046712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EXEMESTANEACTIVE INGREDIENTNY22HMQ4BXAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
EXEMESTANEACTIVE MOIETYNY22HMQ4BXAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
MANNITOLINACTIVE INGREDIENT3OWL53L36AAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
SUCROSEINACTIVE INGREDIENTC151H8M554AROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAROMASIN (EXEMESTANE) TABLET [PHARMACIA AND UPJOHN COMPANY]12
EXEMESTANEACTIVE INGREDIENTNY22HMQ4BXAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
EXEMESTANEACTIVE MOIETYNY22HMQ4BXAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAROMASIN (EXEMESTANE) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-7663AROMASIN (EXEMESTANE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]23Current NDC, Legacy NDC, 1 package rows20250126_cf066b7a-032a-416c-8d40-15ba581423e3.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
EXEMESTANEEXEMESTANEMylan Pharmaceuticals Inc.69abd0ff-b200-4d1a-b14a-80e980a8e7812025-12-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 020753
application number: NDA020753
AromasinEXEMESTANEPharmacia & Upjohn Company LLCcf066b7a-032a-416c-8d40-15ba581423e32025-12-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 020753
application number: NDA020753
ndc (product): 0009-7663

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
261317Aromasin 25 MG Oral TabletPSNcf066b7a-032a-416c-8d40-15ba581423e324
310261exemestane 25 MG Oral TabletPSNcf066b7a-032a-416c-8d40-15ba581423e324
261317exemestane 25 MG Oral Tablet [Aromasin]SBDcf066b7a-032a-416c-8d40-15ba581423e324
310261exemestane 25 MG Oral TabletSCDcf066b7a-032a-416c-8d40-15ba581423e324
261317Aromasin 25 MG Oral TabletSYcf066b7a-032a-416c-8d40-15ba581423e324
261317Aromasin 25 MG Oral TabletPSNf0b31daa-0792-43d5-af08-8b6a864dc90a1
310261exemestane 25 MG Oral TabletPSNf0b31daa-0792-43d5-af08-8b6a864dc90a1
261317exemestane 25 MG Oral Tablet [Aromasin]SBDf0b31daa-0792-43d5-af08-8b6a864dc90a1
310261exemestane 25 MG Oral TabletSCDf0b31daa-0792-43d5-af08-8b6a864dc90a1
261317Aromasin 25 MG Oral TabletSYf0b31daa-0792-43d5-af08-8b6a864dc90a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-7663-040000976630430 TABLET in 1 BOTTLE (0009-7663-04) 30 tablet1999-10-210000-00-00NoNoCurrent