ENGERIX-B
- Product NDC
- 50090-1706
- 11-digit product format
- 500901706
- Labeler code
- 50090
- Product ID
- 50090-1706_303fb9ec-177f-4f87-bc9c-b193f09441ae
- 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
- 2007-04-25
- Marketing end
- 0000-00-00
- Substance
- HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
- Active strength
- 10 ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-1706-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0733-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use ENGERIX-B safely and effectively. See full prescribing information for ENGERIX-B. ENGERIX-B [Hepatitis B Vaccine (Recombinant)] Suspension for Intramuscular Injection Initial U.S. Approval: 1989 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1706-0 | ENGERIX-B | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 13 | |
| 50090-1706-9 | ENGERIX-B | .5 mL in 1 VIAL | INJECTION, SUSPENSION | .5 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1706-0 | ML - Milliliter | 50090-1706 | 20960e5b-008f-419e-a8d4-d3687ef4102f | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1706 | ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS] | 13 | Legacy NDC, 2 package rows | 20200121_9a4037a2-6c63-457a-8d6f-2fd05d926ea2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 798430 | ENGERIX-B pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe | PSN | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798429 | hepatitis B vaccine (recombinant) pediatric/adolescent 10 MCG in 0.5 ML Prefilled Syringe | PSN | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798430 | 0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe [Engerix-B] | SBD | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798429 | 0.5 ML hepatitis B surface antigen vaccine 0.02 MG/ML Prefilled Syringe | SCD | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798430 | 0.5 ML Engerix-B Pediatric 20 MCG/ML Prefilled Syringe | SY | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798430 | Engerix-B 10 MCG per 0.5 ML Prefilled Syringe | SY | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798430 | Engerix-B, Hepatitis B Surface Antigen Vaccine, Adsorbed (Pediatric Dose) 0.5 ML Prefilled Syringe | SY | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798429 | hepatitis B surface antigen vaccine 0.01 MG per 0.5 ML Prefilled Syringe | SY | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
| 798429 | hepatitis B surface antigen vaccine 10 MCG per 0.5 ML Prefilled Syringe | SY | 9a4037a2-6c63-457a-8d6f-2fd05d926ea2 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-1706-0 | 50090170600 | 10 VIAL in 1 CARTON (50090-1706-0) > .5 mL in 1 VIAL (50090-1706-9) | 10 vial | 2007-04-25 | 0000-00-00 | No | No | Current |
| 50090-1706-9 | 50090170609 | .5 mL in 1 VIAL | Historical |