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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-452-37302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62756-452-36302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-452-37ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62756-452-36ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-452-370efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62756-452-360efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-452-37ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62756-452-36ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62756-452-37367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62756-452-36367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213224-001BYNFEZIA PENOCTREOTIDE ACETATEEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213224-001103428502038-05-15Drug product2024-10-18
N213224-001110521962040-11-03U-40072024-10-18
N213224-001110521962040-11-03U-40082024-10-18
N213224-001110521962040-11-03U-40092024-10-18
N213224-001112469912040-11-03U-40072024-10-18
N213224-001112469912040-11-03U-40082024-10-18
N213224-001112469912040-11-03U-40092024-10-18
N213224-001115345532040-11-03U-40072024-10-18
N213224-001115345532040-11-03U-40082024-10-18
N213224-001115345532040-11-03U-40092024-10-18
N213224-001123504752041-12-29U-40072025-07-23
N213224-001123504752041-12-29U-40082025-07-23
N213224-001123504752041-12-29U-40092025-07-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-272680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N213224-001BYNFEZIA PEN7MG/2.8ML (2.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N213224-001BYNFEZIA PEN7MG/2.8ML (2.5MG/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27d06236e962d9…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N213224-001BYNFEZIA PENEQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2020-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N213224-001BYNFEZIA PENEQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2020-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N213224-001BYNFEZIA PENEQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2020-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N213224-001BYNFEZIA PENEQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2020-01-28c0c555d07b60…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N213224-001BYNFEZIA PENEQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2024-09-27a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N213224-001103428502038-05-15Drug product2024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001110521962040-11-03U-40072024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001110521962040-11-03U-40082024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001110521962040-11-03U-40092024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001112469912040-11-03U-40072024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001112469912040-11-03U-40082024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001112469912040-11-03U-40092024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001115345532040-11-03U-40072024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001115345532040-11-03U-40082024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001115345532040-11-03U-40092024-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001123504752041-12-29U-40072025-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001123504752041-12-29U-40082025-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213224-001123504752041-12-29U-40092025-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001103428502038-05-15Drug product2024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001110521962040-11-03U-40072024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001110521962040-11-03U-40082024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001110521962040-11-03U-40092024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001112469912040-11-03U-40072024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001112469912040-11-03U-40082024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001112469912040-11-03U-40092024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001115345532040-11-03U-40072024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001115345532040-11-03U-40082024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001115345532040-11-03U-40092024-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001123504752041-12-29U-40072025-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001123504752041-12-29U-40082025-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213224-001123504752041-12-29U-40092025-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N213224-001103428502038-05-15Drug product2024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001110521962040-11-03U-40072024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001110521962040-11-03U-40082024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001110521962040-11-03U-40092024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001112469912040-11-03U-40072024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001112469912040-11-03U-40082024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001112469912040-11-03U-40092024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001115345532040-11-03U-40072024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001115345532040-11-03U-40082024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001115345532040-11-03U-40092024-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001123504752041-12-29U-40072025-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001123504752041-12-29U-40082025-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N213224-001123504752041-12-29U-40092025-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N213224-001103428502038-05-15Drug product2024-10-18fd3edfee7708…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75R0U2568IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2360543Internal RxNorm lookup
2360548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20ed4e79-ad4c-426f-859d-83790c00439bAvailable on FDA.report

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, Related label table
NDCEffectiveRelated label
62756-452-362025-02-07These 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
62756-452-372025-02-07These 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
62756-452-362023-01-30These 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
62756-452-372023-01-30These 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

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
BYNFEZIA PenOCTREOTIDE ACETATESun Pharmaceutical Industries, Inc.20ed4e79-ad4c-426f-859d-83790c00439b2025-02-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 213224
application number: NDA213224
ndc (product): 62756-452

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