Everolimus

Product NDC
49884-127
11-digit product format
498840127
Labeler code
49884
Product ID
49884-127_b474c768-50e2-44da-accf-f1bd3d49ab20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Everolimus
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA207934
Marketing category
ANDA
Marketing start
2019-12-10
Marketing end
2026-07-31
Substance
EVEROLIMUS
Active strength
7.5 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag
No
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 productproduct49884-127DDiscontinued by firm2026-08-17
excluded packagepackage49884-12749884-127-91DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct49884-127IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49884-12749884-127-91IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207934-001EVEROLIMUSEVEROLIMUS2.5MGTABLET / ORAL2019-12-09
A207934-002EVEROLIMUSEVEROLIMUS5MGTABLET / ORAL2019-12-09
A207934-003EVEROLIMUSEVEROLIMUS7.5MGTABLET / ORAL2019-12-09
A207934-004EVEROLIMUSEVEROLIMUS10MGTABLET / ORAL2020-12-09

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 · 154 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207934-001EVEROLIMUS2.5MGTABLET / ORAL2019-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207934-002EVEROLIMUS5MGTABLET / ORAL2019-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207934-003EVEROLIMUS7.5MGTABLET / ORAL2019-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07A207934-004EVEROLIMUS10MGTABLET / ORAL2020-12-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207934-001EVEROLIMUS2.5MGTABLET / ORAL2019-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207934-002EVEROLIMUS5MGTABLET / ORAL2019-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207934-003EVEROLIMUS7.5MGTABLET / ORAL2019-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207934-004EVEROLIMUS10MGTABLET / ORAL2020-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-001EVEROLIMUS2.5MGTABLET / ORALAB2019-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-002EVEROLIMUS5MGTABLET / ORALAB2019-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-003EVEROLIMUS7.5MGTABLET / ORALAB2019-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-004EVEROLIMUS10MGTABLET / ORALAB2020-12-09d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 142 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207934-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207934-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207934-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207934-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207934-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207934-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207934-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207934-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207934-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207934-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207934-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207934-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207934-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207934-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207934-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207934-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207934-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207934-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207934-004AB179d66fd596c7…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
807eb842-6749-6eff-f9ce-2751c69fde93Product name420260122
151279ee-9f3c-b884-3327-05b3fa99d863Product name620251027

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-127-52Everolimus1 in 1 BLISTER PACKTABLET123
49884-127-91Everolimus28 in 1 CARTONTABLET2823

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-127-52EA - Each49884-12748a5b3c3-2b43-4744-87d8-e54336621be612020-01-03
49884-127-91EA - Each49884-12727e4f5c3-5019-4300-adb9-42052c2e966d12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-127EVEROLIMUS TABLET [ENDO USA, INC.]21Current NDC, Legacy NDC, 2 package rows20240709_45d54974-3fc4-4237-a2fa-3158ca1a8105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845507everolimus 10 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
998189everolimus 2.5 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
845515everolimus 5 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
1119400everolimus 7.5 MG Oral TabletPSN45d54974-3fc4-4237-a2fa-3158ca1a810523
845507everolimus 10 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523
998189everolimus 2.5 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523
845515everolimus 5 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523
1119400everolimus 7.5 MG Oral TabletSCD45d54974-3fc4-4237-a2fa-3158ca1a810523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-127-52498840127521 in 1 BLISTER PACKHistorical
49884-127-914988401279128 BLISTER PACK in 1 CARTON (49884-127-91) / 1 TABLET in 1 BLISTER PACK (49884-127-52) 28 blister pack2019-12-102026-07-31NoNoCurrent