Nabi-HB
- Product NDC
- 69800-4203
- 11-digit product format
- 698004203
- Labeler code
- 69800
- Product ID
- 69800-4203_3271ce4f-1742-b3b7-e063-6294a90a541d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hepatitis B Immune Globulin (Human)
- Dosage form
- LIQUID
- Route
- INTRAMUSCULAR
- Labeler
- ADMA Biologics, Inc.
- Application
- BLA103945
- Marketing category
- BLA
- Marketing start
- 2001-10-23
- Substance
- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN
- Active strength
- 1560 [iU]/5mL
- Pharmacologic classes
- Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nabi-HB
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN | 1560 [iU]/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XII270YC6M |
| Rxcui | 1658125, 1658127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69800-4203-1 | Nabi-HB | 1 in 1 CARTON | LIQUID | 1 | | 8 |
| 69800-4203-2 | Nabi-HB | 5 mL in 1 VIAL, SINGLE-USE | LIQUID | 5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69800-4203 | NABI-HB (HEPATITIS B IMMUNE GLOBULIN (HUMAN)) LIQUID [ADMA BIOLOGICS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250416_47fe1a99-5078-4b89-84fa-9e8387baec5c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69800-4203-1 | 69800420301 | 1 VIAL, SINGLE-USE in 1 CARTON (69800-4203-1) / 5 mL in 1 VIAL, SINGLE-USE (69800-4203-2) | | 2001-10-23 | 0000-00-00 | No | No | Current |
| 69800-4203-2 | 69800420302 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | | | | | Historical |