FDA.reportPublic FDA data

Pegasys

Product NDC
82154-0449
11-digit product format
821540449
Labeler code
82154
Product ID
82154-0449_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
2002-10-16
Substance
PEGINTERFERON ALFA-2A
Active strength
180 ug/mL
Pharmacologic classes
Interferon alpha [EPC], Interferon-alpha [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 82154-0449

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/mL

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
82154-0449-1Pegasys1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION144
82154-0449-1Pegasys1 in 1 BOXINJECTION, SOLUTION144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82154-0449-1ML - Milliliter82154-044968738870-66f0-461a-b719-c99d9256e7dd12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82154-0449PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [PHARMAAND GMBH]43Current NDC, Legacy NDC, 2 package rows20241225_d9290e5b-6d40-2318-e053-2995a90a9916.zip

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82154-0449-1821540449011 VIAL, SINGLE-USE in 1 BOX (82154-0449-1) / 1 mL in 1 VIAL, SINGLE-USE2002-10-160000-00-00NoNoCurrent