FDA.reportPublic FDA data

Otezla

Product NDC
55513-137
11-digit product format
555130137
Labeler code
55513
Product ID
55513-137_d869faaf-a5ad-4b12-b427-06587d17787e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apremilast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amgen, Inc
Application
NDA205437
Marketing category
NDA
Marketing start
2020-02-26
Substance
APREMILAST
Active strength
30 mg/1
Pharmacologic classes
Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APREMILAST30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUP7QBP99PN
Rxcui1492732, 1492738, 1492740, 1492742, 1492744, 1492746, 1492747, 1492748, 1605454, 1605455, 2682429, 2682430, 2682431, 2682432, 2723448, 2723452, 2724366, 2724367

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60f3bca3-f66c-4779-8fd1-16dc6df0a73eProduct name620250818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-137-60Otezla60 in 1 BOTTLETABLET, FILM COATED6034
55513-137-95Otezla1 in 1 CARTONTABLET, FILM COATED134
55513-137-95Otezla28 in 1 BLISTER PACKTABLET, FILM COATED2834

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-137-28EA - Each55513-1370e085751-b776-4ce9-ae90-fd3a04ac915112020-07-13
55513-137-60EA - Each55513-137021b79c2-72c3-4d0c-ac4f-357ca8ab8d1312020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-137OTEZLA (APREMILAST) TABLET, FILM COATED OTEZLA (APREMILAST) KIT [AMGEN INC]28Current NDC, Legacy NDC, 3 package rows20240509_f6b1f516-4972-4d82-bced-113e47b41cc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724367{14 (24 HR apremilast 75 MG Extended Release Oral Tablet [Otezla]) / 4 (apremilast 10 MG Oral Tablet [Otezla]) / 4 (apremilast 20 MG Oral Tablet [Otezla]) / 19 (apremilast 30 MG Oral Tablet [Otezla]) } Pack [Otezla 28-Day 10/20/30/75 Starter Pack]BPCKf6b1f516-4972-4d82-bced-113e47b41cc534
2682432{4 (apremilast 10 MG Oral Tablet [Otezla]) / 23 (apremilast 20 MG Oral Tablet [Otezla]) } Pack [Otezla 14-Day 10/20 Starter Pack]BPCKf6b1f516-4972-4d82-bced-113e47b41cc534
1492748{4 (apremilast 10 MG Oral Tablet [Otezla]) / 4 (apremilast 20 MG Oral Tablet [Otezla]) / 19 (apremilast 30 MG Oral Tablet [Otezla]) } Pack [Otezla 14-Day 10/20/30 Starter Pack]BPCKf6b1f516-4972-4d82-bced-113e47b41cc534
1605455{4 (apremilast 10 MG Oral Tablet [Otezla]) / 4 (apremilast 20 MG Oral Tablet [Otezla]) / 47 (apremilast 30 MG Oral Tablet [Otezla]) } Pack [Otezla 28-Day 10/20/30 Starter Pack]BPCKf6b1f516-4972-4d82-bced-113e47b41cc534
2682430{4 (apremilast 10 MG Oral Tablet [Otezla]) / 51 (apremilast 20 MG Oral Tablet [Otezla]) } Pack [Otezla 28-Day 10/20 Starter Pack]BPCKf6b1f516-4972-4d82-bced-113e47b41cc534
2724366{14 (24 HR apremilast 75 MG Extended Release Oral Tablet) / 4 (apremilast 10 MG Oral Tablet) / 4 (apremilast 20 MG Oral Tablet) / 19 (apremilast 30 MG Oral Tablet) } PackGPCKf6b1f516-4972-4d82-bced-113e47b41cc534
2682431{4 (apremilast 10 MG Oral Tablet) / 23 (apremilast 20 MG Oral Tablet) } PackGPCKf6b1f516-4972-4d82-bced-113e47b41cc534
1492747{4 (apremilast 10 MG Oral Tablet) / 4 (apremilast 20 MG Oral Tablet) / 19 (apremilast 30 MG Oral Tablet) } PackGPCKf6b1f516-4972-4d82-bced-113e47b41cc534
1605454{4 (apremilast 10 MG Oral Tablet) / 4 (apremilast 20 MG Oral Tablet) / 47 (apremilast 30 MG Oral Tablet) } PackGPCKf6b1f516-4972-4d82-bced-113e47b41cc534
2682429{4 (apremilast 10 MG Oral Tablet) / 51 (apremilast 20 MG Oral Tablet) } PackGPCKf6b1f516-4972-4d82-bced-113e47b41cc534
1492732apremilast 10 MG Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492740apremilast 20 MG Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492744apremilast 30 MG Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2723448apremilast 75 MG 24HR Extended Release Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2682431apremilast starter pack 10 MG (4), 20 MG (23) Oral Tablet 14-Day PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492747apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (19) Oral Tablet 14-Day PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2724366apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (19), 75 MG XR (14) Oral Tablet 28-Day PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1605454apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (47) Oral Tablet 28-Day PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2682429apremilast starter pack 10 MG (4), 20 MG (51) Oral Tablet 28-Day PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492738Otezla 10 MG Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2682432Otezla 14-Day 10/20 Starter PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492748Otezla 14-Day 10/20/30 Starter PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492742Otezla 20 MG Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2682430Otezla 28-Day 10/20 Starter PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1605455Otezla 28-Day 10/20/30 Starter PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2724367Otezla 28-Day 10/20/30/75 Starter PackPSNf6b1f516-4972-4d82-bced-113e47b41cc534
1492746Otezla 30 MG Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
2723452Otezla XR 75 MG 24HR Extended Release Oral TabletPSNf6b1f516-4972-4d82-bced-113e47b41cc534
272345224 HR apremilast 75 MG Extended Release Oral Tablet [Otezla]SBDf6b1f516-4972-4d82-bced-113e47b41cc534
1492738apremilast 10 MG Oral Tablet [Otezla]SBDf6b1f516-4972-4d82-bced-113e47b41cc534
1492742apremilast 20 MG Oral Tablet [Otezla]SBDf6b1f516-4972-4d82-bced-113e47b41cc534
1492746apremilast 30 MG Oral Tablet [Otezla]SBDf6b1f516-4972-4d82-bced-113e47b41cc534
272344824 HR apremilast 75 MG Extended Release Oral TabletSCDf6b1f516-4972-4d82-bced-113e47b41cc534
1492732apremilast 10 MG Oral TabletSCDf6b1f516-4972-4d82-bced-113e47b41cc534
1492740apremilast 20 MG Oral TabletSCDf6b1f516-4972-4d82-bced-113e47b41cc534
1492744apremilast 30 MG Oral TabletSCDf6b1f516-4972-4d82-bced-113e47b41cc534
2682431apremilast 14-day 10/20 starter packSYf6b1f516-4972-4d82-bced-113e47b41cc534
1492747apremilast 14-day 10/20/30 starter packSYf6b1f516-4972-4d82-bced-113e47b41cc534
2682429apremilast 28-day 10/20 starter packSYf6b1f516-4972-4d82-bced-113e47b41cc534
1605454apremilast 28-day 10/20/30 starter packSYf6b1f516-4972-4d82-bced-113e47b41cc534
2723448apremilast 75 MG 24HR Extended Release Oral TabletSYf6b1f516-4972-4d82-bced-113e47b41cc534
2724366apremilast starter pack 10 MG (4), 20 MG (4), 30 MG (19), 75 MG XR (14) Oral Tablet 28-Day PackSYf6b1f516-4972-4d82-bced-113e47b41cc534
1492738Otezla 10 MG Oral TabletSYf6b1f516-4972-4d82-bced-113e47b41cc534
2682432Otezla 14-Day 10/20 Starter PackSYf6b1f516-4972-4d82-bced-113e47b41cc534
1492748Otezla 14-Day 10/20/30 Starter PackSYf6b1f516-4972-4d82-bced-113e47b41cc534
1492742Otezla 20 MG Oral TabletSYf6b1f516-4972-4d82-bced-113e47b41cc534
2682430Otezla 28-Day 10/20 Starter PackSYf6b1f516-4972-4d82-bced-113e47b41cc534
1605455Otezla 28-Day 10/20/30 Starter PackSYf6b1f516-4972-4d82-bced-113e47b41cc534
2724367Otezla 28-Day 10/20/30/75 Starter PackSYf6b1f516-4972-4d82-bced-113e47b41cc534
1492746Otezla 30 MG Oral TabletSYf6b1f516-4972-4d82-bced-113e47b41cc534
2723452Otezla XR 75 MG 24HR Extended Release Oral TabletSYf6b1f516-4972-4d82-bced-113e47b41cc534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-137-28555130137281 BLISTER PACK in 1 CARTON (55513-137-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-02-260000-00-00NoNoCurrent
55513-137-5055513013750500 TABLET, FILM COATED in 1 BOTTLE (55513-137-50) 2020-06-290000-00-00NoNoCurrent
55513-137-605551301376060 TABLET, FILM COATED in 1 BOTTLE (55513-137-60) 2020-02-260000-00-00NoNoCurrent
55513-137-95555130137951 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-02-260000-00-00NoNoCurrent