FDA.reportPublic FDA data

Mycapssa

Product NDC
69880-120
11-digit product format
698800120
Labeler code
69880
Product ID
69880-120_1f0f9540-123a-49d7-b1d2-0c150dd5f26a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amryt Pharmaceuticals Designated Activity Company
Application
NDA208232
Marketing category
NDA
Marketing start
2020-07-06
Substance
OCTREOTIDE
Active strength
20 mg/1
Pharmacologic classes
Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRWM8CCW8GP
Rxcui2380611, 2380617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
813db1d8-6534-4d2d-be9e-8d2c20a55edaProduct name120241217
a6ddfef5-d553-2919-73fa-8aede2a8ab27Product name520240823
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69880-120-28Mycapssa7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE77
69880-120-28Mycapssa4 in 1 DOSE PACKCAPSULE, DELAYED RELEASE47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69880-120-28EA - Each69880-1209f4f9cf1-0358-485d-b419-8900695cef4a12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69880-120MYCAPSSA (OCTREOTIDE) CAPSULE, DELAYED RELEASE [AMRYT PHARMACEUTICALS DESIGNATED ACTIVITY COMPANY]6Current NDC, Legacy NDC, 2 package rows20230916_62a5e1eb-b48e-4ea6-8781-f75e490b17e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2380617Mycapssa 20 MG Delayed Release Oral CapsulePSN62a5e1eb-b48e-4ea6-8781-f75e490b17e47
2380611octreotide 20 MG Delayed Release Oral CapsulePSN62a5e1eb-b48e-4ea6-8781-f75e490b17e47
2380617octreotide 20 MG Delayed Release Oral Capsule [Mycapssa]SBD62a5e1eb-b48e-4ea6-8781-f75e490b17e47
2380611octreotide 20 MG Delayed Release Oral CapsuleSCD62a5e1eb-b48e-4ea6-8781-f75e490b17e47
2380617Mycapssa 20 MG Delayed Release Oral CapsuleSY62a5e1eb-b48e-4ea6-8781-f75e490b17e47
2380611octreotide (as octreotide acetate) 20 MG Delayed Release Oral CapsuleSY62a5e1eb-b48e-4ea6-8781-f75e490b17e47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69880-120-28698800120284 BLISTER PACK in 1 DOSE PACK (69880-120-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2020-07-060000-00-00NoNoCurrent