HYLENEX Recombinant
- Product NDC
- 50090-4534
- 11-digit product format
- 500904534
- Labeler code
- 50090
- Product ID
- 50090-4534_022f7985-c63d-40b2-941b-760a1590ee9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hyaluronidase (Human Recombinant)
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- BLA021859
- Marketing category
- BLA
- Marketing start
- 2005-12-02
- Marketing end
- 0000-00-00
- Substance
- HYALURONIDASE (HUMAN RECOMBINANT)
- Active strength
- 150 [USP'U]/mL
- Pharmacologic classes
- Endoglycosidase [EPC],Glycoside Hydrolases [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4534-0 | 2023-02-07 | C162847 | 48780-1 | f386c64a-444a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use Initial U.S. Approval: 2005 |
| 50090-4534-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-444a-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use Initial U.S. Approval: 2005 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4534 | HYLENEX RECOMBINANT (HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 9 | Legacy NDC | 20230208_75f75f29-e369-449d-aa46-179ae02d1fe9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4534-0 | 50090453400 | 1 mL in 1 VIAL (50090-4534-0) | 1 ml | 2019-09-18 | 0000-00-00 | No | No | Current |