AMPHADASE
- Product NDC
- 0548-9090
- 11-digit product format
- 005489090
- Labeler code
- 0548
- Product ID
- 0548-9090_188cabde-5b1f-4083-8b6c-5dcb85f728d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hyaluronidase
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- BLA021665
- Marketing category
- BLA
- Marketing start
- 2004-10-26
- Substance
- HYALURONIDASE
- Active strength
- 150 [USP'U]/mL
- Pharmacologic classes
- Endoglycosidase [EPC], Glycoside Hydrolases [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMPHADASE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYALURONIDASE | 150 [USP'U]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8KOG53Z5EM |
| Rxcui | 238271, 542925 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0548-9090-10 | AMPHADASE | 10 in 1 CARTON | INJECTION | 10 | | 11 |
| 0548-9090-10 | AMPHADASE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| hyaluronidase | ACTIVE INGREDIENT | 8KOG53Z5EM | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
| hyaluronidase | ACTIVE MOIETY | 8KOG53Z5EM | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
| calcium chloride | INACTIVE INGREDIENT | M4I0D6VV5M | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
| thimerosal | INACTIVE INGREDIENT | 2225PI3MOV | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0548-9090 | AMPHADASE (HYALURONIDASE ) INJECTION [AMPHASTAR PHARMACEUTICALS, INC. ] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240910_8396ea96-7cb5-4e26-87a4-90bca9c3c6dd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0548-9090-10 | 00548909010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0548-9090-10) / 1 mL in 1 VIAL, SINGLE-DOSE | 2004-10-26 | 0000-00-00 | No | No | Current |