ENGERIX-B
- Product NDC
- 50090-1223
- 11-digit product format
- 500901223
- Labeler code
- 50090
- Product ID
- 50090-1223_f61147dc-ce4b-477d-9e84-4c5b363e1a2f
- Type
- VACCINE
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- A-S Medication Solutions
- Application
- BLA103239
- Marketing category
- BLA
- Marketing start
- 2007-03-28
- Substance
- HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 20 ug/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ENGERIX-B
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 20 ug/mL |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-1223-0 | ENGERIX-B | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 42 |
| 50090-1223-1 | ENGERIX-B | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 42 |
| 50090-1223-1 | ENGERIX-B | 1 in 1 POUCH | INJECTION, SUSPENSION | 1 | | 42 |
| 50090-1223-2 | ENGERIX-B | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 42 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1223 | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] | 42 | Current NDC, Legacy NDC, 4 package rows | 20250516_dcecf9e0-6c28-4964-9ddb-9379705fa26c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-1223-0 | 50090122300 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 50090-1223-1 | 50090122301 | 1 VIAL, SINGLE-DOSE in 1 POUCH (50090-1223-1) / 1 mL in 1 VIAL, SINGLE-DOSE | | 2007-03-28 | No | No | Historical |
| 50090-1223-2 | 50090122302 | 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-1223-2) / 1 mL in 1 VIAL, SINGLE-DOSE (50090-1223-0) | | 2007-03-28 | No | No | Historical |