Revlimid

Product NDC
59572-415
11-digit product format
595720415
Labeler code
59572
Product ID
59572-415_b5eadec8-aa2b-43ec-b0d6-e5b0c3da08cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Celgene Corporation
Application
NDA021880
Marketing category
NDA
Marketing start
2006-06-29
Substance
LENALIDOMIDE
Active strength
15 mg/1
Pharmacologic classes
Thalidomide Analog [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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021880-001REVLIMIDLENALIDOMIDE5MGCAPSULE / ORALABRLD2005-12-27
N021880-002REVLIMIDLENALIDOMIDE10MGCAPSULE / ORALABRLD2005-12-27
N021880-003REVLIMIDLENALIDOMIDE15MGCAPSULE / ORALABRLD2006-06-29
N021880-004REVLIMIDLENALIDOMIDE25MGCAPSULE / ORALABRLD, RS2006-06-29
N021880-005REVLIMIDLENALIDOMIDE2.5MGCAPSULE / ORALABRLD2011-12-21
N021880-006REVLIMIDLENALIDOMIDE20MGCAPSULE / ORALABRLD2013-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N021880-001AB
N021880-002AB
N021880-003AB
N021880-004AB
N021880-005AB
N021880-006AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021880-00174658002027-04-27Drug substance, Drug product
N021880-00187419292028-03-08U-19832014-06-17
N021880-00274658002027-04-27Drug substance, Drug product
N021880-00287419292028-03-08U-19832014-06-17
N021880-00374658002027-04-27Drug substance, Drug product
N021880-00387419292028-03-08U-19832014-06-17
N021880-00474658002027-04-27Drug substance, Drug product
N021880-00487419292028-03-08U-19832014-06-17
N021880-00574658002027-04-27Drug substance, Drug product2012-01-17
N021880-00587419292028-03-08U-19832014-06-17
N021880-00674658002027-04-27Drug substance, Drug product
N021880-00687419292028-03-08U-19832014-06-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N021880-001ODE-2412026-05-28
N021880-001ODE-2452026-05-28
N021880-002ODE-2412026-05-28
N021880-002ODE-2452026-05-28
N021880-003ODE-2412026-05-28
N021880-003ODE-2452026-05-28
N021880-004ODE-2412026-05-28
N021880-004ODE-2452026-05-28
N021880-005ODE-2412026-05-28
N021880-005ODE-2452026-05-28
N021880-006ODE-2412026-05-28
N021880-006ODE-2452026-05-28

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-005REVLIMID2.5MGCAPSULE / ORALABRLD2011-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-006REVLIMID20MGCAPSULE / ORALABRLD2013-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-005REVLIMID2.5MGCAPSULE / ORALABRLD2011-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-006REVLIMID20MGCAPSULE / ORALABRLD2013-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-005REVLIMID2.5MGCAPSULE / ORALABRLD2011-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-006REVLIMID20MGCAPSULE / ORALABRLD2013-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-005REVLIMID2.5MGCAPSULE / ORALABRLD2011-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-006REVLIMID20MGCAPSULE / ORALABRLD2013-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-005REVLIMID2.5MGCAPSULE / ORALABRLD2011-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-006REVLIMID20MGCAPSULE / ORALABRLD2013-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-005REVLIMID2.5MGCAPSULE / ORALABRLD2011-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-006REVLIMID20MGCAPSULE / ORALABRLD2013-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-001REVLIMID5MGCAPSULE / ORALABRLD2005-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-002REVLIMID10MGCAPSULE / ORALABRLD2005-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-003REVLIMID15MGCAPSULE / ORALABRLD2006-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-004REVLIMID25MGCAPSULE / ORALABRLD, RS2006-06-292680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 198 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021880-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021880-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021880-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021880-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021880-004AB12680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 74 · 2,922 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021880-00174658002027-04-27Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00187419292028-03-08U-19832014-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00274658002027-04-27Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00287419292028-03-08U-19832014-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00374658002027-04-27Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00387419292028-03-08U-19832014-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00474658002027-04-27Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00487419292028-03-08U-19832014-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00574658002027-04-27Drug substance, Drug product2012-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00587419292028-03-08U-19832014-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00674658002027-04-27Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-00687419292028-03-08U-19832014-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00174658002027-04-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00187419292028-03-08U-19832014-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00274658002027-04-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00287419292028-03-08U-19832014-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00374658002027-04-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00387419292028-03-08U-19832014-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00474658002027-04-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00487419292028-03-08U-19832014-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00574658002027-04-27Drug substance, Drug product2012-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00587419292028-03-08U-19832014-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00674658002027-04-27Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-00687419292028-03-08U-19832014-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021880-00174658002027-04-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00187419292028-03-08U-19832014-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00274658002027-04-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00287419292028-03-08U-19832014-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00374658002027-04-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00387419292028-03-08U-19832014-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00474658002027-04-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00487419292028-03-08U-19832014-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00574658002027-04-27Drug substance, Drug product2012-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00587419292028-03-08U-19832014-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00674658002027-04-27Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021880-00687419292028-03-08U-19832014-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-00174658002027-04-27Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-00187419292028-03-08U-19832014-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-00274658002027-04-27Drug substance, Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-00287419292028-03-08U-19832014-06-17fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 27 · 1,062 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N021880-001ODE-2412026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-001ODE-2452026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-002ODE-2412026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-002ODE-2452026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-003ODE-2412026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-003ODE-2452026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-004ODE-2412026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-004ODE-2452026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-005ODE-2412026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-005ODE-2452026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-006ODE-2412026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021880-006ODE-2452026-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-001ODE-2412026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-001ODE-2452026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-002ODE-2412026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-002ODE-2452026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-003ODE-2412026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-003ODE-2452026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-004ODE-2412026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-004ODE-2452026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-005ODE-2412026-05-2831067a03dcf5…
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2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021880-006ODE-2452026-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021880-001ODE-2412026-05-286a471c1ec25d…
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2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-001ODE-2412026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-001ODE-2452026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-002ODE-2412026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021880-002ODE-2452026-05-28fd3edfee7708…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENALIDOMIDE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F0P408N6V4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
602910Internal RxNorm lookup
602912Internal RxNorm lookup
616114Internal RxNorm lookup
616116Internal RxNorm lookup
643712Internal RxNorm lookup
643714Internal RxNorm lookup
643720Internal RxNorm lookup
643722Internal RxNorm lookup
1242231Internal RxNorm lookup
1242233Internal RxNorm lookup
1428947Internal RxNorm lookup
1429367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5fa97bf5-28a2-48f1-8955-f56012d296beAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba3b6b9d-cf27-aec0-3395-500a538c6915Product name620260306

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59572-415-00Revlimid100 in 1 BOTTLECAPSULE10040
59572-415-21Revlimid21 in 1 BOTTLECAPSULE2140

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59572-415-00EA - Each59572-41540a5aec3-805c-43a1-b318-d26bb0c6955d12012-07-24
59572-415-21EA - Each59572-415d4c84bfa-81c7-467d-a16b-fc4b517e3ecb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LENALIDOMIDEACTIVE INGREDIENTF0P408N6V4REVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]20
LENALIDOMIDEACTIVE MOIETYF0P408N6V4REVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]20
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKREVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]20
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48REVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-415REVLIMID (LENALIDOMIDE) CAPSULE [CELGENE CORPORATION]40Current NDC, Legacy NDC, 2 package rows20230408_5fa97bf5-28a2-48f1-8955-f56012d296be.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevlimidLENALIDOMIDECelgene Corporation5fa97bf5-28a2-48f1-8955-f56012d296be2023-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021880
application number: NDA021880
ndc (product): 59572-415

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
643712lenalidomide 15 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
1242231lenalidomide 2.5 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
1428947lenalidomide 20 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
643720lenalidomide 25 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
602912lenalidomide 5 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
616114Revlimid 10 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
643714Revlimid 15 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
1242233Revlimid 2.5 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
1429367Revlimid 20 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
643722Revlimid 25 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
616116Revlimid 5 MG Oral CapsulePSN5fa97bf5-28a2-48f1-8955-f56012d296be40
616114lenalidomide 10 MG Oral Capsule [Revlimid]SBD5fa97bf5-28a2-48f1-8955-f56012d296be40
643714lenalidomide 15 MG Oral Capsule [Revlimid]SBD5fa97bf5-28a2-48f1-8955-f56012d296be40
1242233lenalidomide 2.5 MG Oral Capsule [Revlimid]SBD5fa97bf5-28a2-48f1-8955-f56012d296be40
1429367lenalidomide 20 MG Oral Capsule [Revlimid]SBD5fa97bf5-28a2-48f1-8955-f56012d296be40
643722lenalidomide 25 MG Oral Capsule [Revlimid]SBD5fa97bf5-28a2-48f1-8955-f56012d296be40
616116lenalidomide 5 MG Oral Capsule [Revlimid]SBD5fa97bf5-28a2-48f1-8955-f56012d296be40
602910lenalidomide 10 MG Oral CapsuleSCD5fa97bf5-28a2-48f1-8955-f56012d296be40
643712lenalidomide 15 MG Oral CapsuleSCD5fa97bf5-28a2-48f1-8955-f56012d296be40
1242231lenalidomide 2.5 MG Oral CapsuleSCD5fa97bf5-28a2-48f1-8955-f56012d296be40
1428947lenalidomide 20 MG Oral CapsuleSCD5fa97bf5-28a2-48f1-8955-f56012d296be40
643720lenalidomide 25 MG Oral CapsuleSCD5fa97bf5-28a2-48f1-8955-f56012d296be40
602912lenalidomide 5 MG Oral CapsuleSCD5fa97bf5-28a2-48f1-8955-f56012d296be40
616114Revlimid 10 MG Oral CapsuleSY5fa97bf5-28a2-48f1-8955-f56012d296be40
643714Revlimid 15 MG Oral CapsuleSY5fa97bf5-28a2-48f1-8955-f56012d296be40
1242233Revlimid 2.5 MG Oral CapsuleSY5fa97bf5-28a2-48f1-8955-f56012d296be40
1429367Revlimid 20 MG Oral CapsuleSY5fa97bf5-28a2-48f1-8955-f56012d296be40
643722Revlimid 25 MG Oral CapsuleSY5fa97bf5-28a2-48f1-8955-f56012d296be40
616116Revlimid 5 MG Oral CapsuleSY5fa97bf5-28a2-48f1-8955-f56012d296be40

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59572-415-0059572041500100 CAPSULE in 1 BOTTLE (59572-415-00) 100 capsule2006-07-070000-00-00NoNoCurrent
59572-415-215957204152121 CAPSULE in 1 BOTTLE (59572-415-21) 21 capsule2006-07-070000-00-00NoNoCurrent