Pegasys
- Product NDC
- 82154-0449
- Requested package NDC
- 82154-0449-1
- 11-digit product format
- 821540449
- Labeler code
- 82154
- Product ID
- 82154-0449_5df7144e-dde3-c0ef-e063-6394a90a99c7
- 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
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pegasys
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEGINTERFERON ALFA-2A | 180 ug/mL |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| Q46947FE7K | Internal UNII lookup |
Harmonized RxCUI identifiers#
RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 351270 | Internal RxNorm lookup |
| 352297 | Internal RxNorm lookup |
| 731326 | Internal RxNorm lookup |
| 731328 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82154-0449-1 | Pegasys | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | | 44 |
| 82154-0449-1 | Pegasys | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 44 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82154-0449 | PEGASYS (PEGINTERFERON ALFA-2A) INJECTION, SOLUTION [PHARMAAND GMBH] | 43 | Current NDC, Legacy NDC, 2 package rows | 20241225_d9290e5b-6d40-2318-e053-2995a90a9916.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103964 | Pegasys | peginterferon alfa-2a | 351(a) | Rx | 2026-10-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82154-0449-1 | 82154044901 | 1 VIAL, SINGLE-USE in 1 BOX (82154-0449-1) / 1 mL in 1 VIAL, SINGLE-USE | 2002-10-16 | 0000-00-00 | No | No | Current |