Rapivab
- Product NDC
- 61364-181
- 11-digit product format
- 613640181
- Labeler code
- 61364
- Product ID
- 61364-181_905b7a99-4ba6-4e95-b4e4-a843ddbb20b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- peramivir
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Seqirus USA Inc.
- Application
- NDA206426
- Marketing category
- NDA
- Marketing start
- 2014-12-20
- Marketing end
- 0000-00-00
- Substance
- PERAMIVIR
- Active strength
- 600 mg/60mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 90fc134d-a739-4fd1-b7e8-f9aaabd24b77 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61364-181-03 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-0ff0-fd44-e053-dadaa90aa01b | These highlights do not include all the information needed to use RAPIVAB safely and effectively. See full prescribing information for RAPIVAB. RAPIVAB ® (peramivir injection), for intravenous use Initial U.S. Approval: [2014] |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61364-181-01 | Rapivab | 20 mL in 1 VIAL, GLASS | SOLUTION | 20 | 7 | |
| 61364-181-03 | Rapivab | 3 in 1 CARTON | SOLUTION | 3 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61364-181-01 | ML - Milliliter | 61364-181 | 66173613-ff45-49b6-bb5f-bf3cd2a70494 | 1 | 2015-01-05 |
| 61364-181-03 | ML - Milliliter | 61364-181 | 929831d0-4474-4b87-9a3a-7b79a9b33101 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Peramivir | ACTIVE INGREDIENT | QW7Y7ZR15U | RAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.] | 2 | |
| Peramivir Anhydrous | ACTIVE MOIETY | 9ZS94HQO3B | RAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.] | 2 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | RAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.] | 2 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | RAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.] | 2 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | RAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | RAPIVAB (PERAMIVIR) SOLUTION [BIOCRYST PHARMACEUTICALS, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1598082 | peramivir 200 MG in 20 ML Injection | PSN | 7fdedaec-9e53-4a37-a4e4-a301c8a251b8 | 7 |
| 876203 | Rapivab 200 MG in 20 ML Injection | PSN | 7fdedaec-9e53-4a37-a4e4-a301c8a251b8 | 7 |
| 876203 | 20 ML peramivir 10 MG/ML Injection [Rapivab] | SBD | 7fdedaec-9e53-4a37-a4e4-a301c8a251b8 | 7 |
| 1598082 | 20 ML peramivir 10 MG/ML Injection | SCD | 7fdedaec-9e53-4a37-a4e4-a301c8a251b8 | 7 |
| 1598082 | peramivir 200 MG per 20 ML Injection | SY | 7fdedaec-9e53-4a37-a4e4-a301c8a251b8 | 7 |
| 876203 | Rapivab 200 MG per 20 ML Injection | SY | 7fdedaec-9e53-4a37-a4e4-a301c8a251b8 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61364-181-01 | 61364018101 | 20 mL in 1 VIAL, GLASS | 20 ml | Historical | ||||
| 61364-181-03 | 61364018103 | 3 VIAL, GLASS in 1 CARTON (61364-181-03) > 20 mL in 1 VIAL, GLASS (61364-181-01) | 2014-12-20 | 0000-00-00 | No | No | Current |