FDA.reportPublic FDA data

Mycapssa

Product NDC
10122-550
11-digit product format
101220550
Labeler code
10122
Product ID
10122-550_84ca5e5f-886b-4216-b748-f7dad1201db0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Octreotide
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Chiesi USA, Inc.
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
10122-550-28Mycapssa7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE76
10122-550-28Mycapssa4 in 1 DOSE PACKCAPSULE, DELAYED RELEASE46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-550-28EA - Each10122-5507872f30e-6fff-459d-9e8b-231c1212a13012026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-550MYCAPSSA (OCTREOTIDE) CAPSULE, DELAYED RELEASE [CHIESI USA, INC.]5Current NDC, 2 package rows20240824_58d80bc6-bdfb-4908-93e7-aace447c8d1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2380617Mycapssa 20 MG Delayed Release Oral CapsulePSN58d80bc6-bdfb-4908-93e7-aace447c8d1a6
2380611octreotide 20 MG Delayed Release Oral CapsulePSN58d80bc6-bdfb-4908-93e7-aace447c8d1a6
2380617octreotide 20 MG Delayed Release Oral Capsule [Mycapssa]SBD58d80bc6-bdfb-4908-93e7-aace447c8d1a6
2380611octreotide 20 MG Delayed Release Oral CapsuleSCD58d80bc6-bdfb-4908-93e7-aace447c8d1a6
2380617Mycapssa 20 MG Delayed Release Oral CapsuleSY58d80bc6-bdfb-4908-93e7-aace447c8d1a6
2380611octreotide (as octreotide acetate) 20 MG Delayed Release Oral CapsuleSY58d80bc6-bdfb-4908-93e7-aace447c8d1a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10122-550-28101220550284 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2020-07-06NoNoHistorical