RELENZA
- Product NDC
- 68258-3030
- 11-digit product format
- 682583030
- Labeler code
- 68258
- Product ID
- 68258-3030_342b7e19-49d6-4d0b-950a-cc00f4b79924
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zanamivir
- Dosage form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Dispensing Solutions Inc.
- Application
- NDA021036
- Marketing category
- NDA
- Marketing start
- 2002-12-22
- Marketing end
- 0000-00-00
- Substance
- ZANAMIVIR
- Active strength
- 5 mg/1
- Pharmacologic classes
- Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf3f65a9-7280-6c6a-2c61-3b31509b45f9 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-3030-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d1a0-621f-e053-dbdaa90a74ad | These highlights do not include all the information needed to use RELENZA safely and effectively. See full prescribing information for RELENZA. RELENZA (zanamivir) Inhalation Powder, for oral inhalation Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-3030-1 | RELENZA | 5 in 1 CARTON | POWDER | 5 | 1 | |
| 68258-3030-1 | RELENZA | 4 in 1 PACKAGE | POWDER | 4 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ZANAMIVIR | ACTIVE INGREDIENT | L6O3XI777I | RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.] | 1 | |
| ZANAMIVIR | ACTIVE MOIETY | L6O3XI777I | RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-3030 | RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.] | 1 | Legacy NDC, 2 package rows | 20100303_12ff22f6-20b5-4fa8-9028-58f87e169ff5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 759473 | RELENZA DISKHALER 5 MG/INHAL Dry Powder Inhaler, 20 Blisters | PSN | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
| 759471 | zanamivir 5 MG/INHAL Dry Powder Inhaler, 20 Blisters | PSN | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
| 759473 | 20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler [Relenza] | SBD | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
| 759471 | 20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler | SCD | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
| 759473 | 20 ACTUAT Relenza 5 MG/ACTUAT Dry Powder Inhaler | SY | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
| 759473 | Relenza 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT | SY | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
| 759471 | zanamivir 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT | SY | 12ff22f6-20b5-4fa8-9028-58f87e169ff5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68258-3030-1 | 68258303001 | 5 in 1 CARTON | Historical |