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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rotarix
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN | 1000 [CCID_50]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-740-02 | Rotarix | 1.5 mL in 1 APPLICATOR | SOLUTION | 1.5 | | 31 |
| 58160-740-21 | Rotarix | 10 in 1 CARTON | SOLUTION | 10 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN | ACTIVE INGREDIENT | KZ3L01D2PC | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN | ACTIVE MOIETY | KZ3L01D2PC | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| CYSTINE | INACTIVE INGREDIENT | 48TCX9A1VT | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| DEXTRAN 1 | INACTIVE INGREDIENT | I8LHQ0D645 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| FERRIC NITRATE | INACTIVE INGREDIENT | N8H8402XOB | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| GLUTAMINE | INACTIVE INGREDIENT | 0RH81L854J | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| PHENOLSULFONPHTHALEIN | INACTIVE INGREDIENT | I6G9Y0J1OJ | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| SODIUM PHOSPHATE | INACTIVE INGREDIENT | SE337SVY37 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| SODIUM PYRUVATE | INACTIVE INGREDIENT | POD38AIF08 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
| TYROSINE | INACTIVE INGREDIENT | 42HK56048U | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) KIT [GLAXOSMITHKLINE BIOLOGICALS SA] | 13 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-740 | ROTARIX (ROTAVIRUS VACCINE, LIVE, ORAL) SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | 29 | Current NDC, 2 package rows | 20250327_f3182470-1965-4e20-dbaf-e3506f893ea5.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125265 | Rotarix | Rotavirus Vaccine, Live, Oral | 351(a) | Disc | 2026-06-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58160-740-02 | 58160074002 | 1.5 mL in 1 APPLICATOR | 1.5 ml | | | | Historical |
| 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 | Current |