ENGERIX-B
- Product NDC
- 68258-3042
- 11-digit product format
- 682583042
- Labeler code
- 68258
- Product ID
- 68258-3042_f11aa988-f958-4f75-ab9b-89c24998faff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hepatitis B Vaccine (Recombinant)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Dispensing Solutions Inc.
- Application
- BLA103239
- Marketing category
- BLA
- Marketing start
- 2009-05-28
- Marketing end
- 0000-00-00
- Substance
- HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 20 ug/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68258-3042-1 | ENGERIX-B | 1 mL in 1 VIAL | INJECTION, SUSPENSION | 1 | | 1 |
| 68258-3042-1 | ENGERIX-B | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | ACTIVE INGREDIENT | 9GCJ1L5D1P | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | |
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | ACTIVE MOIETY | 9GCJ1L5D1P | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-3042 | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [DISPENSING SOLUTIONS INC.] | 1 | Legacy NDC, 2 package rows | 20100303_4d930f24-4ddb-488d-9e79-3f495972733b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68258-3042-1 | 68258304201 | 1 mL in 1 VIAL | 1 ml | Historical |