FDA.reportPublic FDA data

Pegasys

Product NDC
82154-0451
Requested package NDC
82154-0451-4
11-digit product format
821540451
Labeler code
82154
Product ID
82154-0451_3c18e4a2-193f-ef4e-e063-6394a90a56b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
peginterferon alfa-2a
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
pharmaand GmbH
Application
BLA103964
Marketing category
BLA
Marketing start
2011-03-29
Substance
PEGINTERFERON ALFA-2A
Active strength
180 ug/.5mL
Pharmacologic classes
Interferon alpha [EPC], Interferon-alpha [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGINTERFERON ALFA-2A180 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q46947FE7KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351270Internal RxNorm lookup
352297Internal RxNorm lookup
731326Internal RxNorm lookup
731328Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9290e5b-6d40-2318-e053-2995a90a9916Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
1b855a15-1625-459d-8f07-6d0458a03c6bProduct name120210513
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82154-0451-4Pegasys4 in 1 PACKETINJECTION, SOLUTION444
82154-0451-4Pegasys1 in 1 BOXINJECTION, SOLUTION144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82154-0451-4ML - Milliliter82154-04515274eb70-087c-4de6-b59c-5d2e304583cb12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82154-0451PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [PHARMAAND GMBH]43Current NDC, Legacy NDC, 2 package rows20241225_d9290e5b-6d40-2318-e053-2995a90a9916.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
PegasysPEGINTERFERON ALFA-2Apharmaand GmbHd9290e5b-6d40-2318-e053-2995a90a99162026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103964
ndc (package): 82154-0451-4
ndc (product): 82154-0451
ndc11 (package): 82154045104

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103964Pegasyspeginterferon alfa-2a351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
731328Pegasys 180 MCG in 0.5 ML Prefilled SyringePSNd9290e5b-6d40-2318-e053-2995a90a991644
352297Pegasys 180 MCG in 1 ML InjectionPSNd9290e5b-6d40-2318-e053-2995a90a991644
731326peginterferon alfa-2a 180 MCG in 0.5 ML Prefilled SyringePSNd9290e5b-6d40-2318-e053-2995a90a991644
351270peginterferon alfa-2a 180 MCG in 1 ML InjectionPSNd9290e5b-6d40-2318-e053-2995a90a991644
7313280.5 ML peginterferon alfa-2a 0.36 MG/ML Prefilled Syringe [Pegasys]SBDd9290e5b-6d40-2318-e053-2995a90a991644
3522971 ML peginterferon alfa-2a 0.18 MG/ML Injection [Pegasys]SBDd9290e5b-6d40-2318-e053-2995a90a991644
7313260.5 ML peginterferon alfa-2a 0.36 MG/ML Prefilled SyringeSCDd9290e5b-6d40-2318-e053-2995a90a991644
3512701 ML peginterferon alfa-2a 0.18 MG/ML InjectionSCDd9290e5b-6d40-2318-e053-2995a90a991644
7313280.5 ML Pegasys 0.36 MG/ML Prefilled SyringeSYd9290e5b-6d40-2318-e053-2995a90a991644
3522971 ML Pegasys 0.18 MG/ML InjectionSYd9290e5b-6d40-2318-e053-2995a90a991644
352297Pegasys 0.18 MG/ML Injectable SolutionSYd9290e5b-6d40-2318-e053-2995a90a991644
731328Pegasys 180 MCG per 0.5 ML Prefilled SyringeSYd9290e5b-6d40-2318-e053-2995a90a991644
352297Pegasys 180 MCG/ML Injectable SolutionSYd9290e5b-6d40-2318-e053-2995a90a991644
731326peginterferon alfa-2a 0.18 MG per 0.5 ML Prefilled SyringeSYd9290e5b-6d40-2318-e053-2995a90a991644
731326peginterferon alfa-2a 180 MCG per 0.5 ML Prefilled SyringeSYd9290e5b-6d40-2318-e053-2995a90a991644
351270peginterferon alfa-2a 180 MCG/ML Injectable SolutionSYd9290e5b-6d40-2318-e053-2995a90a991644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82154-0451-4821540451041 PACKET in 1 BOX (82154-0451-4) / 4 SYRINGE, GLASS in 1 PACKET / .5 mL in 1 SYRINGE, GLASS1 packet2011-03-290000-00-00NoNoCurrent