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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pegasys
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEGINTERFERON ALFA-2A | 180 ug/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q46947FE7K |
| Rxcui | 351270, 352297, 731326, 731328 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 1b855a15-1625-459d-8f07-6d0458a03c6b | Product name | 1 | 20210513 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82154-0449-1 | ML - Milliliter | 82154-0449 | 68738870-66f0-461a-b719-c99d9256e7dd | 1 | 2022-05-04 |
DailyMed Dashboard NDC Coverage#
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 731328 | Pegasys 180 MCG in 0.5 ML Prefilled Syringe | PSN | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 352297 | Pegasys 180 MCG in 1 ML Injection | PSN | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731326 | peginterferon alfa-2a 180 MCG in 0.5 ML Prefilled Syringe | PSN | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 351270 | peginterferon alfa-2a 180 MCG in 1 ML Injection | PSN | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731328 | 0.5 ML peginterferon alfa-2a 0.36 MG/ML Prefilled Syringe [Pegasys] | SBD | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 352297 | 1 ML peginterferon alfa-2a 0.18 MG/ML Injection [Pegasys] | SBD | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731326 | 0.5 ML peginterferon alfa-2a 0.36 MG/ML Prefilled Syringe | SCD | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 351270 | 1 ML peginterferon alfa-2a 0.18 MG/ML Injection | SCD | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731328 | 0.5 ML Pegasys 0.36 MG/ML Prefilled Syringe | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 352297 | 1 ML Pegasys 0.18 MG/ML Injection | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 352297 | Pegasys 0.18 MG/ML Injectable Solution | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731328 | Pegasys 180 MCG per 0.5 ML Prefilled Syringe | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 352297 | Pegasys 180 MCG/ML Injectable Solution | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731326 | peginterferon alfa-2a 0.18 MG per 0.5 ML Prefilled Syringe | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 731326 | peginterferon alfa-2a 180 MCG per 0.5 ML Prefilled Syringe | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
| 351270 | peginterferon alfa-2a 180 MCG/ML Injectable Solution | SY | d9290e5b-6d40-2318-e053-2995a90a9916 | 44 |
Packages#
| 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 |