TEPEZZA
- Product NDC
- 75987-130
- 11-digit product format
- 759870130
- Labeler code
- 75987
- Product ID
- 75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- teprotumumab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Horizon Therapeutics USA, Inc.
- Application
- BLA761143
- Marketing category
- BLA
- Marketing start
- 2020-01-21
- Substance
- TEPROTUMUMAB
- Active strength
- 500 mg/1
- Pharmacologic classes
- Insulin-like Growth Factor-1 Receptor Inhibitor [EPC], Insulin-like Growth Factor-1 Receptor Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TEPEZZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEPROTUMUMAB | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Y64GQ0KC0A |
| Rxcui | 2274807, 2274812 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75987-130-15 | TEPEZZA | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 17 |
| 75987-130-15 | TEPEZZA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75987-130 | TEPEZZA (TEPROTUMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HORIZON THERAPEUTICS USA, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250223_3e6c54a1-cefd-4a5b-a855-ab9f268b6cce.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 |
|---|
| 75987-130-15 | 75987013015 | 1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2020-01-21 | 0000-00-00 | No | No | Current |