FDA.reportPublic FDA data

BYNFEZIA Pen

Product NDC
62756-452
11-digit product format
627560452
Labeler code
62756
Product ID
62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
octreotide acetate
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA213224
Marketing category
NDA
Marketing start
2025-02-24
Substance
OCTREOTIDE ACETATE
Active strength
2.5 mg/mL
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
BYNFEZIA Pen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTREOTIDE ACETATE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75R0U2568I
Rxcui2360543, 2360548

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8f3fde6c-976e-4e4c-8ed4-542294fcc0efProduct name120210115
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
467fba3a-c020-419e-8102-aeb9c0ea15ecProduct name120200616
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62756-452-362025-02-07C16284748780-1f386c649-e9a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BYNFEZIA PEN safely and effectively. See full prescribing information for BYNFEZIA PEN. BYNFEZIA PEN ® (octreotide acetate) injection, for subcutaneous use Initial U.S. Approval: 1988
62756-452-372025-02-07C16284748780-1f386c649-e9a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BYNFEZIA PEN safely and effectively. See full prescribing information for BYNFEZIA PEN. BYNFEZIA PEN ® (octreotide acetate) injection, for subcutaneous use Initial U.S. Approval: 1988
62756-452-362023-01-30C16284748780-1f386c649-e9a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BYNFEZIA PEN safely and effectively. See full prescribing information for BYNFEZIA PEN. BYNFEZIA PEN ® (octreotide acetate) injection, for subcutaneous use Initial U.S. Approval: 1988
62756-452-372023-01-30C16284748780-1f386c649-e9a1-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BYNFEZIA PEN safely and effectively. See full prescribing information for BYNFEZIA PEN. BYNFEZIA PEN ® (octreotide acetate) injection, for subcutaneous use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-452-36BYNFEZIA Pen2.8 mL in 1 CARTRIDGEINJECTION2.85
62756-452-36BYNFEZIA Pen1 in 1 CARTONINJECTION15
62756-452-37BYNFEZIA Pen2 in 1 CARTONINJECTION25
62756-452-37BYNFEZIA Pen2.8 mL in 1 CARTRIDGEINJECTION2.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-452-36ML - Milliliter62756-452e8172a04-8a00-4086-a324-c9feed1765df12020-06-05
62756-452-37ML - Milliliter62756-452481af9c4-1d97-4e50-a0cf-1c03a3605fb812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-452BYNFEZIA PEN (OCTREOTIDE ACETATE) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 4 package rows20250225_20ed4e79-ad4c-426f-859d-83790c00439b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360548Bynfezia 2500 MCG/ML in 2.8 ML Pen InjectorPSN20ed4e79-ad4c-426f-859d-83790c00439b5
2360543octreotide 2500 MCG/ML in 2.8 ML Pen InjectorPSN20ed4e79-ad4c-426f-859d-83790c00439b5
23605482.8 ML octreotide 2.5 MG/ML Pen Injector [Bynfezia]SBD20ed4e79-ad4c-426f-859d-83790c00439b5
23605432.8 ML octreotide 2.5 MG/ML Pen InjectorSCD20ed4e79-ad4c-426f-859d-83790c00439b5
2360548Bynfezia 2.5 MG/ML per 2.8 ML Pen InjectorSY20ed4e79-ad4c-426f-859d-83790c00439b5
2360548Bynfezia 2500 MCG/ML per 2.8 ML Pen InjectorSY20ed4e79-ad4c-426f-859d-83790c00439b5
2360543octreotide (as octreotide acetate) 2.5 MG/ML per 2.8 ML Pen InjectorSY20ed4e79-ad4c-426f-859d-83790c00439b5
2360543octreotide (as octreotide acetate) 2500 MCG/ML per 2.8 ML Pen InjectorSY20ed4e79-ad4c-426f-859d-83790c00439b5
2360543octreotide (as octreotide acetate) 7000 MCG per 2.8 ML Pen InjectorSY20ed4e79-ad4c-426f-859d-83790c00439b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-452-36627560452361 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE1 cartridge2025-02-240000-00-00NoNoCurrent
62756-452-37627560452372 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE2 cartridge2025-02-240000-00-00NoNoCurrent