ActHIB
- Product NDC
- 49281-545
- 11-digit product format
- 492810545
- Labeler code
- 49281
- Product ID
- 49281-545_1a0012dd-f83c-47ca-bb9f-f83c42ce9f25
- Type
- VACCINE
- Nonproprietary name
- HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
- Dosage form
- KIT
- Labeler
- Sanofi Vaccines US Inc.
- Application
- BLA103935
- Marketing category
- BLA
- Marketing start
- 1993-03-30
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ActHIB
- Listing expiration
- 2027-12-31
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49281-545-03 | ActHIB | 1 in 1 CARTON | KIT | 1 | 20 | |
| 49281-547-58 | ActHIB | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 2.5 mL | 10 ug in 0.5mL | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49281-545-03 | EA - Each | 49281-545 | 05ffdc38-f2d1-4291-8316-fd092b7364bb | 1 | 2016-06-14 |
| 49281-545-05 | EA - Each | 49281-545 | b0f38e4d-d606-4288-9eb2-52ff7ff662e8 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | ACTIVE INGREDIENT | FLV5I5W26R | ACTHIB (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) KIT [SANOFI PASTEUR INC.] | 5 | |
| HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN | ACTIVE MOIETY | FLV5I5W26R | ACTHIB (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) KIT [SANOFI PASTEUR INC.] | 5 | |
| FORMALDEHYDE | INACTIVE INGREDIENT | 1HG84L3525 | ACTHIB (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) KIT [SANOFI PASTEUR INC.] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49281-545 | ACTHIB (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) KIT [SANOFI PASTEUR INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20250403_8143d01c-4911-40db-95b2-47f3ebea2a7d.zip |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103935 | Acthib,Omnihib | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1300468 | ActHIB vaccine 0.5 ML Injection | PSN | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300466 | Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for ActHIB) 0.5 mL Injection | PSN | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300468 | 0.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection [ActHIB] | SBD | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300466 | 0.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection | SCD | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300468 | 0.5 ML ActHIB 0.068 MG/ML Injection | SY | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300468 | ActHIB (purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG) per 0.5 ML Injection | SY | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300468 | ActHIB 34 MCG per 0.5 ML Injection | SY | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
| 1300466 | purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG per 0.5 ML Injection | SY | 8143d01c-4911-40db-95b2-47f3ebea2a7d | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49281-545-03 | 49281054503 | 1 KIT in 1 CARTON (49281-545-03) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-547-58) * .6 mL in 1 VIAL, SINGLE-DOSE (49281-546-58) | 1 kit | 1993-03-30 | 0000-00-00 | No | No | Current |
| 49281-547-58 | 49281054758 | 0.5 mL in 1 VIAL, SINGLE-DOSE | 0.5 ml | Historical |