ANAVIP
- Product NDC
- 66621-0790
- 11-digit product format
- 666210790
- Labeler code
- 66621
- Product ID
- 66621-0790_b7340824-c214-4942-8b06-0ba59e21091b
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- crotalidae immune F(ab)2(equine)
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Rare Disease Therapeutics, Inc
- Application
- BLA125488
- Marketing category
- BLA
- Marketing start
- 2015-05-06
- Substance
- PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE)
- Active strength
- 12 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ANAVIP
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) | 12 mg/mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66621-0790-1 | ANAVIP | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 24 |
| 66621-0790-2 | ANAVIP | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) | ACTIVE INGREDIENT | 92VV7G83ED | ANAVIP (CROTALIDAE IMMUNE F(AB)2(EQUINE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [RARE DISEASE THERAPUTICS, INC] | 2 | |
| PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) | ACTIVE MOIETY | 92VV7G83ED | ANAVIP (CROTALIDAE IMMUNE F(AB)2(EQUINE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [RARE DISEASE THERAPUTICS, INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66621-0790 | ANAVIP (CROTALIDAE IMMUNE F(AB)2(EQUINE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [RARE DISEASE THERAPEUTICS, INC] | 23 | Current NDC, Legacy NDC, 2 package rows | 20240427_a16596a5-e87e-40c2-8e34-cea5839849c3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66621-0790-1 | 66621079001 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 66621-0790-2 | 66621079002 | 1 VIAL in 1 CARTON (66621-0790-2) / 10 mL in 1 VIAL (66621-0790-1) | 1 vial | 2015-05-06 | 0000-00-00 | No | No | Current |