Rotarix
- Product NDC
- 58160-740
- 11-digit product format
- 581600740
- Labeler code
- 58160
- Product ID
- 58160-740_8bc5afc0-e90f-4404-8379-06e456cfd1cc
- Type
- VACCINE
- Nonproprietary name
- Rotavirus Vaccine, Live, Oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125265
- Marketing category
- BLA
- Marketing start
- 2023-02-01
- Substance
- HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN
- Active strength
- 1000 [CCID_50]/mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], Live Attenuated Rotavirus Vaccine [EPC], Rotavirus Vaccines [CS], Vaccines, Attenuated [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Matched term |
|---|
| KZ3L01D2PC | HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN | HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58160-740-21 | 58160074021 | 10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02) | 10 applicator | 2023-02-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rotarix | GlaxoSmithKline Biologicals SA | 2024-01-24 | VACCINE LABEL | 31 |