Terlivaz
- Product NDC
- 43825-200
- 11-digit product format
- 438250200
- Labeler code
- 43825
- Product ID
- 43825-200_1d0832a2-debc-40bf-8bbe-59383d0bd3c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terlipressin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mallinckrodt Hospital Products Inc.
- Application
- NDA022231
- Marketing category
- NDA
- Marketing start
- 2022-09-14
- Substance
- TERLIPRESSIN
- Active strength
- .85 mg/5mL
- Pharmacologic classes
- Vasopressin Receptor Agonist [EPC], Vasopressin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terlivaz
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERLIPRESSIN | .85 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7Z5X49W53P |
| Rxcui | 2612431, 2612436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43825-200-01 | Terlivaz | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 43825-200-01 | Terlivaz | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43825-200 | TERLIVAZ (TERLIPRESSIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240420_3a35b86c-f451-4fac-8499-43019e4da354.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 |
|---|
| 43825-200-01 | 43825020001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2022-09-14 | 0000-00-00 | No | No | Current |